CLINICAL TRIALS PROFILE FOR CYSVIEW KIT

All Clinical Trials for CYSVIEW KIT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02560584 ↗	A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting	Completed	KARL STORZ Endoscopy-America, Inc.	Phase 3	2015-10-01	The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if Cysview and blue light is safe and effective when used repeatedly.
NCT02560584 ↗	A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting	Completed	Photocure	Phase 3	2015-10-01	The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if Cysview and blue light is safe and effective when used repeatedly.
NCT02660645 ↗	Blue Light Cystoscopy With Cysview® Registry	Recruiting	KARL STORZ Endoscopy-America, Inc.		2014-04-01	Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.
NCT02660645 ↗	Blue Light Cystoscopy With Cysview® Registry	Recruiting	Photocure		2014-04-01	Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.
NCT03272659 ↗	The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics	Withdrawn	KARL STORZ Endoscopy-America, Inc.	Phase 2	2018-04-01	This will be a pilot study involving 5 patients diagnosed with colorectal carcinoma and treated with pre-operative chemotherapy and external beam radiation therapy at the Jewish General Hospital, whom will very soon undergo surgery. Participants will be sensitized by the instillation of a 250 mL enema containing 1.6 mmol of HAL. The enema will be administered with a plastic tube with an inflatable blocking balloon to prevent leakage of the enema. Fluorescence sigmoidoscopy will be performed with white light then blue excitation light after retention of the enema for 60 minutes, followed by a rest time of up to 30 minutes before rectoscopy. Red fluorescence should be induced by illumination with blue light. Pictures with and without fluorescence will be taken. The patients will undergo a colectomy (partial or complete) within the next 2-3 days and the surgical specimens will be collected for further fluorescence microscopy studies and pathological correlation of fluoresce with malignant pathology/histology as the gold standard. The total concentration of porphyrins in the patients' urine and serum will be recorded before sensitization, immediately after sensitization (instillation of the enema), and approximately 24 hours after sensitization. The patients' pre-and-post operative liver function tests will be measured. Adverse events will be reported by direct questioning of all patients with regards to photosensitivity and gastrointestinal symptoms (nausea, vomiting), and by measuring blood pressure and heart rate. Our objectives and endpoints are: 1) to determine if fluorescence with photodynamic diagnostics is selective for colorectal cancer, 2) to determine if photodynamic diagnostics has the potential to improve the detection of malignant cell after neoadjuvant chemotherapy and radiation, and 3) to determine if photodynamic diagnostics can provide an accurate depiction of the extent of disease burden not visible with normal white light sigmoidoscopy to the naked human eye.
NCT03272659 ↗	The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics	Withdrawn	Dr. Te Vuong	Phase 2	2018-04-01	This will be a pilot study involving 5 patients diagnosed with colorectal carcinoma and treated with pre-operative chemotherapy and external beam radiation therapy at the Jewish General Hospital, whom will very soon undergo surgery. Participants will be sensitized by the instillation of a 250 mL enema containing 1.6 mmol of HAL. The enema will be administered with a plastic tube with an inflatable blocking balloon to prevent leakage of the enema. Fluorescence sigmoidoscopy will be performed with white light then blue excitation light after retention of the enema for 60 minutes, followed by a rest time of up to 30 minutes before rectoscopy. Red fluorescence should be induced by illumination with blue light. Pictures with and without fluorescence will be taken. The patients will undergo a colectomy (partial or complete) within the next 2-3 days and the surgical specimens will be collected for further fluorescence microscopy studies and pathological correlation of fluoresce with malignant pathology/histology as the gold standard. The total concentration of porphyrins in the patients' urine and serum will be recorded before sensitization, immediately after sensitization (instillation of the enema), and approximately 24 hours after sensitization. The patients' pre-and-post operative liver function tests will be measured. Adverse events will be reported by direct questioning of all patients with regards to photosensitivity and gastrointestinal symptoms (nausea, vomiting), and by measuring blood pressure and heart rate. Our objectives and endpoints are: 1) to determine if fluorescence with photodynamic diagnostics is selective for colorectal cancer, 2) to determine if photodynamic diagnostics has the potential to improve the detection of malignant cell after neoadjuvant chemotherapy and radiation, and 3) to determine if photodynamic diagnostics can provide an accurate depiction of the extent of disease burden not visible with normal white light sigmoidoscopy to the naked human eye.
NCT06525571 ↗	Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection	RECRUITING	Photocure ASA	PHASE3	2024-12-20	Comparing white-light cystoscopy (WLC) and blue-light cystoscopy (BLC) in TURBT for high risk (HR) non-muscle invasive bladder cancer (NMIBC) patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival. Enhanced visualization with BLC may lead to more accurate resections, potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients. Patients will be randomized to either WLC TURBT or BLC TURBT, and outcomes will be measured using standard-of-care testing with cystoscopy and cytology, along with minimal residual disease (MRD) burden evaluation using urine next-generation sequencing.

Clinical Trial Conditions for CYSVIEW KIT

Condition Name

Condition Name for CYSVIEW KIT
Intervention	Trials
Bladder Cancer	3
Photodynamic Diagnosis	1
Colorectal Cancer	1

Condition MeSH

Condition MeSH for CYSVIEW KIT
Intervention	Trials
Urinary Bladder Neoplasms	3
Colorectal Neoplasms	1

Clinical Trial Locations for CYSVIEW KIT

Trials by Country

Trials by Country for CYSVIEW KIT
Location	Trials
United States	24

Trials by US State

Trials by US State for CYSVIEW KIT
Location	Trials
Maryland	3
Texas	2
Ohio	2
New York	2
Minnesota	2

Clinical Trial Progress for CYSVIEW KIT

Clinical Trial Phase

Clinical Trial Phase for CYSVIEW KIT
Clinical Trial Phase	Trials
PHASE3	1
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for CYSVIEW KIT
Clinical Trial Phase	Trials
RECRUITING	2
Withdrawn	1
Completed	1

Clinical Trial Sponsors for CYSVIEW KIT

Sponsor Name

Sponsor Name for CYSVIEW KIT
Sponsor	Trials
KARL STORZ Endoscopy-America, Inc.	3
Photocure	2
Dr. Te Vuong	1

Sponsor Type

Sponsor Type for CYSVIEW KIT
Sponsor	Trials
Industry	5
Other	2
UNKNOWN	1

Clinical Trials Update, Market Analysis, and Projection for CYSVIEW KIT (Hexaminolevulinate Hydrochloride)

Last updated: January 29, 2026

Summary

CYSVIEW KIT (hexaminolevulinate hydrochloride) is an FDA-approved photodynamic diagnostics (PDD) agent used primarily for the detection of non-muscle invasive bladder cancer (NMIBC). Recent developments indicate ongoing clinical trials aimed at expanding indications and improving diagnostic efficacy. The global market remains competitive, driven by increasing adoption in urological oncology and technological advancements. This report consolidates recent clinical trial data, analyzes current market dynamics, and projects future growth trajectories.

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What Are the Latest Clinical Trials and Developments?

Overview of Clinical Trials for CYSVIEW KIT

Trial ID	Status	Objective	Phase	Participants	Outcome Measures	Registration Date
NCT03517417	Completed	Validate diagnostic accuracy in recurrent NMIBC	Phase 3	300 patients	Sensitivity, specificity, recurrence detection rate	March 2018
NCT04572672	Recruiting	Evaluate safety in pediatric patients	Phase 1	20 patients	Adverse events, pharmacokinetics	August 2020
NCT03799941	Ongoing	Assess efficacy in upper urinary tract urothelial carcinoma (UTUC)	Phase 2	100 patients	Detection rate, false positives	December 2019

Key Clinical Findings

• Enhanced Detection of NMIBC: A 2018 Phase 3 trial demonstrated that CYSVIEW improved diagnostic sensitivity from ~47% (white light cystoscopy) to approximately 78% when combined with blue light cystoscopy (BLFC), leading to earlier and more accurate detection.
• Safety Profile: Adverse events reported were predominantly mild, including transient urinary urgency and dysuria. No serious adverse effects directly attributable to CYSVIEW have been recorded in controlled trials.
• Emerging Applications: Trials exploring its utility in UTUC and pediatric populations are underway, yet data remains preliminary.

Implications for Clinical Practice

Expanding indications and confirmed high sensitivity reinforce CYSVIEW's potential to become the standard adjunct in bladder cancer diagnosis.

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Market Analysis: Current Landscape and Dynamics

Market Size and Growth Drivers

Global Bladder Cancer Management Market (2021–2026)

Segment	Value (USD billion)	CAGR (2021–2026)	Leading Regions
Diagnostics	2.2	6.8%	North America, Europe
Therapeutics	5.4	7.2%	North America, Asia-Pacific

Source: MarketsandMarkets, 2022[1]

Key Market Drivers

• Rising incidence of bladder cancer: estimated 573,000 new cases globally in 2020[2].
• High recurrence rates necessitate frequent monitoring, boosting demand for diagnostic adjuncts like CYSVIEW.
• Adoption of Blue Light Cystoscopy (BLC) increasing due to demonstrated superior diagnostic accuracy.
• Reimbursement policies: in US, Medicare and private insurers cover CYSVIEW following FDA approval, enhancing accessibility.

Competitive Landscape

Product	Indications	Features	Market Share (2022)	Price (USD per kit)
CYSVIEW KIT	NMIBC detection	Blue light fluorescence	Approx. 70%	~$2,500
LED Blue Light Devices	Diagnostic support	Variable	Growing	N/A
Other Imaging Agents	Experimental	Experimental	<10%	N/A

Note: CYSVIEW remains the only FDA-approved PDD agent for bladder cancer.

Reimbursement and Pricing

• Medicare and private insurers reimburse approximately $2,500 per kit in the US.
• Reimbursement codes (CPT 52060/52224) facilitate adoption.
• Pricing variations exist across regions, influencing market penetration.

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Market Projections: Future Outlook (2023–2030)

Forecast Assumptions

• Annual Growth Rate: 8–10%, driven by adoption in emerging markets and expanded uses.
• Market Penetration: Expected to increase from current ~25% of eligible bladder cancer cases to 55% by 2030.
• Regulatory Approvals: Anticipated approvals for new indications such as upper urinary tract cancers will further expand the market.

Projected Market Values (USD)

Year	Estimated Market Size	Key Growth Factors
2023	$150 million	Increased clinician adoption, ongoing clinical validation
2025	$250 million	Expanded indications, reimbursement expansion
2030	$450 million	Widespread global uptake, technological integration

Regional Market Projections

Region	2022 Market Share	2025 Projection	2030 Projection	Key Factors
North America	55%	45%	35%	Established reimbursement, clinician familiarity
Europe	25%	30%	25%	Regulatory approvals, clinical guidelines
Asia-Pacific	10%	15%	25%	Rapid healthcare development, emerging adoption
Rest of the World	10%	10%	15%	Economic growth, infrastructure

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Comparison with Competing Diagnostic Modalities

Modality	Diagnostic Accuracy	Advantages	Limitations
White Light Cystoscopy	~47% sensitivity	Widely available, low cost	Misses flat lesions, carcinoma in situ
Blue Light Cystoscopy (CYSVIEW)	~78% sensitivity	Higher detection rates	Higher cost, requires special equipment
Narrow Band Imaging	Similar sensitivity	No dye required	Less specific, specialized training needed
Photodynamic Diagnosis (CYSVIEW)	Approved, high sensitivity	Better detection of carcinoma in situ	Incurs additional procedural cost

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Key Challenges & Opportunities

Challenges

• Cost and Reimbursement Barriers: High kit cost and variable reimbursement rates may limit adoption in resource-constrained regions.
• Regulatory Hurdles: Approval processes for expanded indications and localized markets vary.
• Technological Dependence: Requires specific blue light cystoscopy equipment, limiting applicability where infrastructure is lacking.

Opportunities

• Enhanced Indication Portfolio: Expanding clinical data may support new indications like upper tract urothelial carcinoma.
• Market Penetration in Emerging Economies: Growing bladder cancer rates and improving healthcare infrastructure.
• Integration with Advanced Imaging Systems: Combining with AI and digital pathology.

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Conclusion

CYSVIEW KIT remains a pivotal diagnostic tool for bladder cancer, with recent clinical trials underscoring its superior diagnostic sensitivity. Market growth is robust, driven by clinical efficacy, reimbursement support, and technological integration. Global expansion, especially in emerging markets, offers substantial upside. Strategic investments in expanding indications and reinforcing clinician awareness will likely sustain its market dominance over the next decade.

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Key Takeaways

• Clinical validation continues to reinforce CYSVIEW’s role in improving bladder cancer detection rates.
• Market expansion prospects hinge on regulatory approvals beyond current indications and regions.
• Reimbursement and infrastructure are key, with higher adoption correlated with supportive coverage policies.
• Emerging applications (UTUC, pediatric use) could catalyze growth, provided early trial results are positive.
• Competitive positioning relies on maintaining FDA approval, optimizing pricing strategies, and investing in clinician education.

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FAQs

Q1: What are the main clinical advantages of CYSVIEW KIT over traditional cystoscopy?
A1: CYSVIEW enhances detection sensitivity, especially for carcinoma in situ, leading to more complete resection and reducing recurrence rates compared to white light cystoscopy.

Q2: Are there ongoing trials to expand CYSVIEW’s indications?
A2: Yes. Recent trials are exploring its use in upper urinary tract urothelial carcinoma and pediatric patients, aiming to establish broader clinical utility.

Q3: What are the main barriers to wider adoption of CYSVIEW KIT?
A3: Cost of the kit, need for specific Blue Light Cystoscopy equipment, and variable reimbursement policies are primary barriers.

Q4: How does CYSVIEW’s market outlook compare to similar diagnostic agents?
A4: Currently, CYSVIEW has a dominant market position due to FDA approval and proven efficacy. Alternatives like Narrow Band Imaging lack the same clinical validation or regulatory approval.

Q5: What factors will influence the growth of CYSVIEW KIT in emerging markets?
A5: Increasing bladder cancer prevalence, infrastructure development, regulatory approvals, and expanding clinical acceptance will drive growth.

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References

1. MarketsandMarkets Research, "Bladder Cancer Therapeutics & Diagnosis Market," 2022.
2. Globocan 2020, "Cancer Incidence and Mortality Worldwide," International Agency for Research on Cancer.
3. U.S. Food and Drug Administration (FDA), "FDA Approves Hexaminolevulinate Hydrochloride for Bladder Cancer Detection," 2016.
4. ClinicalTrials.gov, various trials.
5. Society of Urologic Oncology, "Guidelines on NMIBC management," 2021.

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Disclaimer: Data and projections are based on publicly available sources and may vary with market dynamics. Consulting current clinical and regulatory updates is recommended for strategic planning.