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Completed

NCT Number: NCT06473675

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

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.

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Key information

Conditions

Hysterectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Groupe Hospitalier Saintes - Saint-Jean-d'Angély, Saintes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hysterectomy with adnexal surgery

Procedure

Robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.

Primary outcomes

  1. primary safety endpoint

    Time frame: up to 42 days

    occurrence of Clavien - Dindo grades III-V adverse events

  2. primary performance endpoint

    Time frame: intraoperative

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

Sponsors and collaborators

Lead sponsor

Distalmotion SA

Industry

Collaborators

  • Confinis

Registry information

Official study title

Hysterectomy With Adnexal Surgery Procedures With the DEXTER Robotic System

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2024
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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