NCT04154683

Optical Biopsy in Gynecological Surgery

Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Optical biopsy is a new technology that generates a real-time, cell-based, high-resolution view and analysis of tissues. Observation is instantaneous and non-invasive. This allows reliable and fast diagnosis which facilitates decision making as well as patient management. The investigator have already conducted a feasibility study on the use of this new technology to evaluate ovarian and tubal pre-cancerous lesions in laparoscopy. In this new study, he wants to continue investigations, expand its use to other gynecological pathologies, and demonstrate the benefit of such a non-invasive technology in gynecology on the one hand in the diagnosis of lesions but also to appreciate the margins as accurately as possible surgical excision of tumors and / or endometriosis lesions. The investigator have set up a prospective monocentric descriptive study. The hypothesis is that optical biopsy by Cellvizio® allows to observe in real time microscopically tissues and to characterize them in the field of gynecological surgery

Conditions

• Gynecologic Surgical Procedures

Interventions

Type	Name	Description
DEVICE	Cellvizio®	use of the Cellvizio® optical biopsy

Timeline

• Start date: 2020-06-29
• Primary completion: 2026-06-29
• Completion: 2026-06-29
• First posted: 2019-11-06
• Last updated: 2026-01-15

Locations

2 sites across 1 country: France