Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Women aged 18 years or more

• Informed and signed consent

• Planned surgery under laparoscopy and included in the list below:

‣ unilateral or bilateral salpingectomy

⁃ hysterectomy

⁃ ovariectomy

⁃ surgery of endometriosis

⁃ surgery for cancer of the cervix, endometrium, ovaries

Locations
Other Locations
France
Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon
NOT_YET_RECRUITING
Bron
Service de Gynécologie, HFME, Hospices Civils de Lyon
RECRUITING
Bron
Contact Information
Primary
Gautier CHENE, MD
gautier.chene@chu-lyon.fr
(4) 72 35 58 70
Time Frame
Start Date: 2020-06-29
Estimated Completion Date: 2026-06-29
Participants
Target number of participants: 80
Treatments
Experimental: group using Cellvizio® optical biopsy
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov