Open-label, Uncontrolled Clinical Research Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)
Coologics, Inc
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.
Eligibility
- Age range
- 22–49 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the inclusion criteria. 1. Women between 22-49 years of age and not more than one year since last menses, with the suspected diagnosis of uncomplicated VVC. 2. Able to read and understand English. 3. Able to provide written informed consent and to understand and agree to all study procedures required. 4. Has a smart phone and has the ability to access and use the ValidCare app. 5. Documented Papanicolaou (Pap) test at baseline or during the previous…
Interventions
- Devicevaginal cooling device
medical grade polymer capsule filled with inert fluid (15 cc's)
Locations (10)
- Symphony Clinical ResearchJacksonville, Florida
- Nova Clinical ResearchMiami, Florida
- Pivotal Clinical Research & AssociatesSmyrna, Georgia
- Renew Health Clinical ResearchSnellville, Georgia
- Leavitt Clinical ResearchIdaho Falls, Idaho
- Next Innovative Clinical ResearchChicago, Illinois