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NCT05537727 Clinical Trial

Robotic MIS With Dexter

Hysterectomy Clinical Trial

Official title:
Robotic Minimally Invasive Gynecological, Urological, and General Surgery With Dexter

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05537727
Other study ID # 2021-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 27, 2022
Est. completion date July 2024

Study information
Verified date March 2023
Source Distalmotion SA
Contact Pascal Lehmann
Phone +41215105890
Email pascal.lehmann@distalmotion.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• robotic-assisted surgery
Gynecology: robot-assisted and laparoscopic hysterectomy for benign or low risk malignant disease
• robotic-assisted surgery
Urology: robot-assisted and laparoscopic partial nephrectomy
• robotic-assisted surgery
General surgery: robot-assisted and laparoscopic right colectomy

Locations
Country Name City State
France Hopital Paris Saint-Joseph Paris
France Centre Hospitalier de Saintes Saintes
Germany UKSH Kiel
Switzerland Inselspital Bern
Switzerland CHUV Lausanne

Sponsors (1)
Lead Sponsor Collaborator
Distalmotion SA

Countries where clinical trial is conducted

France,  Germany,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary occurrence of serious (Clavien - Dindo grades III-V), device related adverse events. perioperatively up to 30 days
Primary 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
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