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
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Hysterectomy
• Partial Nephrectomy
• Right Colectomy

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