Hysterectomy With Adnexal Surgery Procedures With the DEXTER Robotic System (The HYPER Study)

Hysterectomy With Adnexal Surgery Procedures With the DEXTER Robotic System

This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.

Study Overview

• Status: Completed
• Conditions: Hysterectomy
• Intervention / Treatment: Procedure: Hysterectomy with adnexal surgery

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• France
  • Saintes, France, 17100
    • Groupe Hospitalier Saintes - Saint-Jean-d'Angély
• Switzerland
  • Baden, Switzerland
    • Kantonsspital Baden
  • Bern, Switzerland
    • Inselspital Bern
  • Interlaken, Switzerland
    • Spitäler FMI AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing a hysterectomy with adnexal surgery for benign disease.

Description

Inclusion Criteria:

• Aged > 18 years
• Patients planned to undergo elective robot-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease; using one camera port, two ports for the manipulating instruments, and additional ports as needed.

Exclusion Criteria:

• Morbidly obese patients (BMI > 40)
• Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
• Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
• Bleeding diathesis
• Pregnancy
• Patients with pacemakers or internal defibrillators
• Any planned concomitant procedures
• Patient deprived of liberty by administrative or judicial decision.
• Participation in another interventional clinical trial

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary performance endpoint	successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach	intraoperative
primary safety endpoint	occurrence of Clavien - Dindo grades III-V adverse events	up to 42 days

Collaborators and Investigators

• Sponsor: Distalmotion SA
• Collaborators: Confinis

Publications and helpful links

General Publications

• Gulz M, Bodet ML, Streich M, Habegger A, Heubner M, Erhardt D, Bogdanovic B, Mueller MD. Multicenter evaluation of the DEXTER(R) Robotic Surgery System for Total Hysterectomy with Adnexal Surgery. J Robot Surg. 2025 Sep 26;19(1):634. doi: 10.1007/s11701-025-02647-0.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Actual): April 2, 2025
• Study Completion (Actual): April 2, 2025

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures; Hysterectomy
• Other Study ID Numbers: 2024-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No