NCT06473688

Brief Summary

This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic cholecystectomy.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

June 21, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

June 19, 2024

Last Update Submit

February 6, 2025

Conditions

Cholecystectomy

Outcome Measures

Primary Outcomes (2)

  • primary safety endpoint

    occurrence of Clavien - Dindo grades III-V adverse events

    up to 30 days

  • primary performance endpoint

    successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach

    intraoperative

Interventions

CholecystectomyPROCEDURE

Robotic-assisted and laparoscopic cholecystectomy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing a cholecystectomy.

You may qualify if:

  • Aged \> 18 years
  • Patients planned to undergo elective robot-assisted and laparoscopic cholecystectomy; using one camera port, two ports for the manipulating instruments, and additional ports as needed.

You may not qualify if:

  • Morbidly obese patients (BMI \> 40)
  • Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
  • Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
  • Bleeding diathesis
  • Pregnancy
  • Patients with pacemakers or internal defibrillators
  • Any planned concomitant procedures
  • Patient deprived of liberty by administrative or judicial decision
  • Participation in another interventional clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Groupe Hospitalier Saintes - Saint-Jean-d'Angély

Saintes, 17100, France

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

Klinik Hirslanden Zürich

Zurich, 8032, Switzerland

Location

MeSH Terms

Interventions

Cholecystectomy

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2024

First Posted

June 25, 2024

Study Start

June 21, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

February 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)FR(1)DE(1)