NCT07123051

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 right colectomy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Aug 2025

Geographic Reach
3 countries

4 active sites

Status
recruiting

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

Study Progress70%
Aug 2025Sep 2026

Study Start

First participant enrolled

August 5, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

August 8, 2025

Last Update Submit

April 10, 2026

Conditions

Right Colectomy

Outcome Measures

Primary Outcomes (2)

  • Primary safety outcome

    Occurrence of Clavien-Dindo grades III-V adverse events

    up to 30 days after surgery

  • Primary efficacy outcome

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

    Intraoperative

Interventions

right colectomyDEVICE

Robotic-assisted right colectomy with the DEXTER robotic surgery system

Eligibility Criteria

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

Adult patients undergoing a right colectomy for malignant or benign indication

You may qualify if:

  • Aged \> 18 years
  • Patient agrees to perform the 30-day follow-up assessment as per standard of care

You may not qualify if:

  • History of radiotherapy on the target surgical area
  • Patients with distant metastasis
  • Any planned concomitant procedures
  • History of major abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CH Châteauroux - Le Blanc

Châteauroux, 36000, France

RECRUITING

Artemed Klinikum München Süd

Munich, 81379, Germany

NOT YET RECRUITING

Spitäler FMI AG

Interlaken, Switzerland

RECRUITING

SRO AG Spital Langenthal

Langenthal, 4900, Switzerland

RECRUITING

Central Study Contacts

Pascal Lehmann

CONTACT

+41215105890pascal.lehmann@distalmotion.com

Study Design

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

Study Record Dates

First Submitted

August 8, 2025

First Posted

August 14, 2025

Study Start

August 5, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

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