CClinicalTrials.gg
CompletedNCT05537727Updated Feb 20, 2025

Robotic MIS With Dexter

An observational study in Hysterectomy, Partial Nephrectomy and Right Colectomy, sponsored by Distalmotion SA. Completed at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Distalmotion SA · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to confirm the perioperative and early postoperative safety and clinical performance of the Dexter Robotic System (Dexter Surgical System, Model DM-L6).

02

Conditions studied

  • Hysterectomy
  • Partial Nephrectomy
  • Right Colectomy
03

In context

Lead sponsor

Distalmotion SA is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The study population will consist of the modified intent-to-treat (mITT) sample. This is defined as the set of patients who were enrolled in the trial and on whom robotic-assisted surgery with Dexter was at least started.

Inclusion criteria

  • Aged ≥ 18 years
  • Patient agrees to perform the 30-day follow-up assessment
  • Able to provide signed Informed Consent, according to local regulation

Exclusion criteria

Exclusion Criteria:

  • Morbidly obese patients.
  • Any and all relative and absolute contraindications to endoscopic surgical technique applicable to the use of conventional endoscopic surgical instruments.
  • Bleeding diathesis.
  • Pregnancy.
  • Patients with pacemakers or internal defibrillators.
  • Any planned concomitant procedures.
  • Patient deprived of liberty by administrative or judicial decision or under legal guardianship.
  • Participation in another interventional clinical trial.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • Devicerobotic-assisted surgery

    Gynecology: robot-assisted and laparoscopic hysterectomy for benign or low risk malignant disease

  • Devicerobotic-assisted surgery

    Urology: robot-assisted and laparoscopic partial nephrectomy

  • Devicerobotic-assisted surgery

    General surgery: robot-assisted and laparoscopic right colectomy

06

What researchers measure

Primary outcomes

  1. occurrence of serious (Clavien - Dindo grades III-V), device related adverse events.

    Time frame: perioperatively up to 30 days

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

    Time frame: intraoperative

07

Study locations

5 sites
  • Hopital Paris Saint-Joseph
    Paris, France
  • Centre Hospitalier de Saintes
    Saintes, France
  • UKSH
    Kiel, 24105, Germany
  • Inselspital
    Bern, 3010, Switzerland
  • CHUV
    Lausanne, 1011, Switzerland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05537727
Lead sponsor
Distalmotion SA
Responsible party
Sponsor
First posted
Sep 13, 2022
Start date
Sep 27, 2022
Primary completion
Jan 9, 2025
Completion
Jan 9, 2025
Last update
Feb 20, 2025

Study contacts

Dieter Hahnloser, MD
principal investigator · CHUV

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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