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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-20

Study Completion Date

2025-04-02

Brief Summary

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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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Detailed Description

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Conditions

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Hysterectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Hysterectomy with adnexal surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No