CVS-Notifier - Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The Critical View of Safety (CVS) is universally recommended to prevent bile duct injuries in laparoscopic cholecystectomy. However, CVS is underutilized and bile duct injuries are not decreasing. The CVS-Notifier SaMD (Software as a Medical Device) reminds surgeons to verify the CVS before dividing the cystic duct, as recommended by guidelines. It is hypothesized that this systematic and timely reminder could improve the implementation of CVS without disturbing surgical workflows.

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

• Man or woman over 18 years old.

• Patient presenting with benign gallbladder disease requiring an elective laparoscopic cholecystectomy.

• Patient without contraindications to anaesthesia or laparoscopic cholecystectomy surgery.

• Patients capable of understanding and providing their written consent to the study.

• Patient affiliated to the French social security system.

Locations
Other Locations
France
Visceral and Digestive Surgery, Nouvel Hôpital Civil
RECRUITING
Strasbourg
Contact Information
Primary
Armelle TAKEDA, PhD
armelle.takeda@ihu-strasbourg.eu
+33341903608
Time Frame
Start Date: 2025-04-03
Estimated Completion Date: 2026-05
Participants
Target number of participants: 40
Treatments
Experimental: Study
Related Therapeutic Areas
Sponsors
Collaborators: Scialytics SAS
Leads: IHU Strasbourg

This content was sourced from clinicaltrials.gov