NCT05537727

Brief 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).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
3 countries

5 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

September 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

September 27, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

2.3 years

First QC Date

September 8, 2022

Last Update Submit

February 18, 2025

Conditions

HysterectomyPartial NephrectomyRight Colectomy

Outcome Measures

Primary Outcomes (2)

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

    perioperatively up to 30 days

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

    intraoperative

Interventions

robotic-assisted surgeryDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hopital Paris Saint-Joseph

Paris, France

Location

Centre Hospitalier de Saintes

Saintes, France

Location

UKSH

Kiel, 24105, Germany

Location

Inselspital

Bern, 3010, Switzerland

Location

CHUV

Lausanne, 1011, Switzerland

Location

MeSH Terms

Interventions

Robotic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Dieter Hahnloser, MD

    CHUV

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 13, 2022

Study Start

September 27, 2022

Primary Completion

January 9, 2025

Study Completion

January 9, 2025

Last Updated

February 20, 2025

Record last verified: 2025-02

Locations

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