Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy

NCT06895200 | Recruiting

• 1 other identifier: 24-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholecystectomy, Laparoscopic

Keywords

Laparoscopic cholecystectomy; Gallbladder; Safety; Critical View of Safety; CVS; Bile Duct Injuries; BDI

Outcome Measures

Primary Outcomes (1)

• Rate of CVS-Notifier SaMD related complications

  The rate of CVS-Notifier SaMD related complications defined as any complications caused directly or indirectly by the device. Postoperative complication will be classified according to the Clavien-Dindo classification (Grade 1 to Grade 5).

  From the day of the procedure up to 30 days after surgery

Secondary Outcomes (4)

• Rate of intraoperative time-out

  The day of the procedure

• Rate of CVS implementation

  The day of the procedure

• Surgeons' acceptance

  The day of the procedure

• Patients' acceptance

  The day of the procedure

Study Arms (1)

Study

EXPERIMENTAL

Device: CVS-Notifier SaMD

Interventions

CVS-Notifier SaMD DEVICE

The CVS-Notifier SaMD reminds surgeons to time-out to check the CVS before the division of the cystic duct.

Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients presenting with malignant gallbladder disease requiring an elective laparoscopic cholecystectomy.
• Pregnant or lactating patient.
• Patient under guardianship or trusteeship.
• Patient under the protection of justice or deprived of liberty.
• Patient in situation of emergency.

Sponsors & Collaborators

• IHU Strasbourg: lead
• Scialytics SAS: collaborator

Study Sites (1)

Visceral and Digestive Surgery, Nouvel Hôpital Civil

Strasbourg, 67000, France

RECRUITING

Study Officials

• Silvana PERRETTA, MD, PhD

  Hopitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armelle TAKEDA, PhD

CONTACT

+33341903608; armelle.takeda@ihu-strasbourg.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 26, 2025
• Study Start: April 3, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)