Trials / Recruiting
RecruitingNCT06983041
Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)
Open-label, Uncontrolled Clinical Research Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- Sponsor
- Coologics, Inc · Industry
- Sex
- Female
- Age
- 22 Years – 49 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to determine clinical cure rate and safety of a proprietary Vaginal Cooling Device (VCD) in women with VCC. In addition, the safety, mycological cure rates, the speed and efficacy of symptom resolution, vaginal hyphae and polymorphonuclear (PMN) scores, and Quality-of-Life (QoL) parameters will be determined.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | vaginal cooling device | medical grade polymer capsule filled with inert fluid (15 cc's) |
Timeline
- Start date
- 2025-05-22
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2025-05-21
- Last updated
- 2026-01-30
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06983041. Inclusion in this directory is not an endorsement.