Robotic MIS With Dexter

NCT ID: NCT05537727

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-27

Study Completion Date

2025-01-09

Brief Summary

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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).

Detailed Description

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Conditions

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Hysterectomy Partial Nephrectomy Right Colectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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robotic-assisted surgery

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

Intervention Type DEVICE

robotic-assisted surgery

Urology: robot-assisted and laparoscopic partial nephrectomy

Intervention Type DEVICE

robotic-assisted surgery

General surgery: robot-assisted and laparoscopic right colectomy

Intervention Type DEVICE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Distalmotion SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dieter Hahnloser, MD

Role: PRINCIPAL_INVESTIGATOR

CHUV

Locations

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Hopital Paris Saint-Joseph

Paris, , France

Site Status

Centre Hospitalier de Saintes

Saintes, , France

Site Status

UKSH

Kiel, , Germany

Site Status

Inselspital

Bern, , Switzerland

Site Status

CHUV

Lausanne, , Switzerland

Site Status

Countries

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France Germany Switzerland

Other Identifiers

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2021-01

Identifier Type: -

Identifier Source: org_study_id

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