Hysterectomy With Adnexal Surgery Procedures With the DEXTER Robotic System (The HYPER Study)
1 other identifier
observational
52
2 countries
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2024
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2024
CompletedStudy Start
First participant enrolled
June 20, 2024
CompletedFirst Posted
Study publicly available on registry
June 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2025
CompletedApril 15, 2026
April 1, 2026
10 months
June 19, 2024
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
primary safety endpoint
occurrence of Clavien - Dindo grades III-V adverse events
up to 42 days
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
Interventions
Robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.
Eligibility Criteria
Adult patients undergoing a hysterectomy with adnexal surgery for benign disease.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Distalmotion SAlead
- Confiniscollaborator
Study Sites (4)
Groupe Hospitalier Saintes - Saint-Jean-d'Angély
Saintes, 17100, France
Kantonsspital Baden
Baden, Switzerland
Inselspital Bern
Bern, Switzerland
Spitäler FMI AG
Interlaken, Switzerland
Related Publications (1)
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.
PMID: 40999110DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2024
First Posted
June 25, 2024
Study Start
June 20, 2024
Primary Completion
April 2, 2025
Study Completion
April 2, 2025
Last Updated
April 15, 2026
Record last verified: 2026-04