CLINICAL TRIALS PROFILE FOR STERILE WATER FOR IRRIGATION

505(b)(2) Clinical Trials for Sterile Water For Irrigation

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Medstar Health Research Institute	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Patient-Centered Outcomes Research Institute	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Penn State College of Medicine	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	University of California, Los Angeles	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	University of Washington	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	University of Wisconsin, Madison	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.

All Clinical Trials for Sterile Water For Irrigation

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	Boston Medical Center	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	Icahn School of Medicine at Mount Sinai	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	Schneider Children's Medical Center, Israel	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	University of Illinois at Chicago	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	University of Tennessee Health Science Center	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	Susan P. Perrine	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.

Clinical Trial Conditions for Sterile Water For Irrigation

Condition Name

Condition Name for Sterile Water For Irrigation
Intervention	Trials
Sinusitis	11
Surgical Site Infection	10
Postoperative Pain	8
Chronic Rhinosinusitis (Diagnosis)	8

Condition MeSH

Condition MeSH for Sterile Water For Irrigation
Intervention	Trials
Infections	34
Sinusitis	30
Infection	27
Pain, Postoperative	23

Clinical Trial Locations for Sterile Water For Irrigation

Trials by Country

Trials by Country for Sterile Water For Irrigation
Location	Trials
United States	193
Egypt	29
Canada	21
Taiwan	10
China	8

Trials by US State

Trials by US State for Sterile Water For Irrigation
Location	Trials
Texas	19
California	17
Missouri	13
Pennsylvania	13
New York	10

Clinical Trial Progress for Sterile Water For Irrigation

Clinical Trial Phase

Clinical Trial Phase for Sterile Water For Irrigation
Clinical Trial Phase	Trials
Phase 4	89
Phase 3	37
Phase 2/Phase 3	14

Clinical Trial Status

Clinical Trial Status for Sterile Water For Irrigation
Clinical Trial Phase	Trials
Completed	127
Not yet recruiting	48
Unknown status	48

Clinical Trial Sponsors for Sterile Water For Irrigation

Sponsor Name

Sponsor Name for Sterile Water For Irrigation
Sponsor	Trials
Cairo University	19
Washington University School of Medicine	8
Ain Shams University	6

Sponsor Type

Sponsor Type for Sterile Water For Irrigation
Sponsor	Trials
Other	407
Industry	37
U.S. Fed	6

Sterile Water for Irrigation: Clinical Trials, Market Analysis, and Projections

Introduction

Sterile Water for Irrigation is a critical component in various medical procedures, serving as an irrigating fluid and pharmaceutic aid. This article delves into the clinical trials, market analysis, and projections for Sterile Water for Irrigation, providing a comprehensive overview of its current and future landscape.

Clinical Indications and Usage

Sterile Water for Irrigation USP is indicated for use as an irrigating fluid and as a pharmaceutic aid. It is particularly useful in endoscopic urological procedures due to its low refractive index, which provides excellent visibility. However, it is not recommended for use in surgical procedures where it could be absorbed by tissues, leading to hemolysis and other complications[1].

Clinical Trials and Studies

Comparison with Other Irrigants

A significant clinical study compared the use of sterile water with 1.5% glycine as irrigation fluids in Transurethral Resection of the Prostate (TURP) procedures. The study found that biochemical changes were significantly less with sterile water compared to glycine. While both fluids had similar outcomes in terms of surgical duration and fluid absorption, sterile water was noted as a safer and more cost-effective alternative, especially in resource-limited settings[4].

Safety and Efficacy

The safety of sterile water has been evaluated in various clinical settings. It is noted for its hypotonic nature, which, while beneficial in some procedures, can be detrimental if absorbed in large quantities during surgery. However, when used appropriately, sterile water does not cause significant complications and is biologically inert[1].

Market Analysis

Current Market Size and Growth

The global Sterile Water for Irrigation market was valued at US$ 2013 million in 2023 and is projected to reach US$ 3357.5 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.3% during the forecast period of 2024-2030[5].

Market Segmentation

The market is segmented based on type (below 500 mL, 500-1000 mL, 1000-2000 mL, above 2000 mL) and application (Medical Devices Irrigation, Wound Debridement). Geographically, the market is divided into regions such as North America, Europe, Asia-Pacific, and others[2][5].

Key Players

Prominent players in the Sterile Water for Irrigation market include McKesson, Medline, B. Braun Medical, Cytiva, SP Services, Bound Tree Medical, Mountainside Medical, ICU Medical, and CDM Lavoisier. These companies are focusing on product portfolio expansion and strategic partnerships to maintain their market presence[2][5].

Market Projections

Growth Drivers

The market is driven by several key factors, including the increasing demand for sterile water in pharmaceutical and biopharmaceutical manufacturing, particularly for the production of vaccines and parenteral solutions. The rise in chronic diseases such as cardiovascular disease, diabetes, and cancer also fuels the demand for injectable solutions, which in turn drives the need for sterile water[3].

Regional Outlook

North America is anticipated to witness significant growth due to extensive demand for sterile water in the synthesis of biopharmaceuticals and the increasing investments in improving pharmaceutical water quality methods. The Asia-Pacific region is also expected to grow substantially due to the expanding healthcare infrastructure and increasing demand for medical devices and wound debridement procedures[2][3].

Competitive Landscape

The market is highly competitive, with leading players engaging in mergers and acquisitions, product launches, and strategic partnerships to enhance their market share. The competitive landscape is further characterized by the presence of both established and emerging players, each contributing to the market's dynamic growth[2][3].

Challenges and Opportunities

Challenges

One of the significant challenges is the potential for hemolysis and systemic complications if sterile water is absorbed in large quantities during surgical procedures. Additionally, the market faces regulatory challenges and the need for continuous quality control to ensure the sterility and safety of the water[1][4].

Opportunities

The increasing demand for generic medicines and the growing need for advanced therapy medicinal products (ATMPs) present lucrative opportunities for market growth. The expansion of healthcare services in emerging markets and the increasing focus on wound care and medical device irrigation also offer significant growth prospects[2][3].

Key Takeaways

• Clinical Indications: Sterile Water for Irrigation is used in endoscopic urological procedures and as a pharmaceutic aid but is not recommended for surgical procedures where tissue absorption is a risk.
• Market Growth: The global market is projected to grow at a CAGR of 7.3% from 2024 to 2030, reaching US$ 3357.5 million by 2030.
• Key Players: Major companies include McKesson, Medline, B. Braun Medical, and others, which are focusing on product expansion and strategic partnerships.
• Growth Drivers: Increasing demand in pharmaceutical and biopharmaceutical manufacturing, and the rise in chronic diseases are key drivers.
• Regional Outlook: North America and Asia-Pacific are expected to be significant growth regions.

FAQs

What are the primary clinical indications for Sterile Water for Irrigation?

Sterile Water for Irrigation is primarily used as an irrigating fluid in endoscopic urological procedures and as a pharmaceutic aid. It is not recommended for use in surgical procedures where it could be absorbed by tissues.

Which companies are the major players in the Sterile Water for Irrigation market?

Major players include McKesson, Medline, B. Braun Medical, Cytiva, SP Services, Bound Tree Medical, Mountainside Medical, ICU Medical, and CDM Lavoisier.

What is the projected growth rate of the Sterile Water for Irrigation market?

The market is projected to grow at a CAGR of 7.3% from 2024 to 2030.

What are the key drivers of the Sterile Water for Irrigation market?

Key drivers include the increasing demand for sterile water in pharmaceutical and biopharmaceutical manufacturing, the rise in chronic diseases, and the growing need for advanced therapy medicinal products (ATMPs).

Which regions are expected to see significant growth in the Sterile Water for Irrigation market?

North America and the Asia-Pacific region are anticipated to witness significant growth due to various factors including demand for biopharmaceuticals and expanding healthcare infrastructure.

Sources

1. Sterile Water for Irrigation: Package Insert / Prescribing Info. Drugs.com.
2. Global Sterile Water for Irrigation Market Size, Trends and Projections. Market Research Intellect.
3. Water for Injection Market to Exceed USD 53.8 Bn by 2031. GlobeNewswire.
4. Biochemical Changes Using Sterile Water and 1.5% Glycine in TURP. LWW Journals.
5. Global Sterile Water for Irrigation Market Research Report 2024. Valuates Reports.