CompletedNot Applicable

Robotic MIS With Dexter

France, Germany, Switzerland100 participantsStarted 2022-09-27

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

occurrence of serious (Clavien - Dindo grades III-V), device related adverse events.

Timeframe: perioperatively up to 30 days

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

Timeframe: intraoperative

Trial details

NCT IDNCT05537727

SponsorDistalmotion SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-01-09

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