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OpenTrials
Completed

NCT Number: NCT07071740

Robotic Minimally Invasive Ventral Hernia Repair With DEXTER

The aim of this clinical investigation is to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing incisional or primary ventral hernia repair.

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Key information

Conditions

Ventral Hernia Repair

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Allgemein öffentliches Krankenhaus Spittal/Drau, Spittal an der Drau, Austria

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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
  • Planned to undergo incisional and primary midline ventral (M2-M4; epigastric, umbilical and infraumbilical) hernia repair smaller and equal to 8cm
  • Patient agrees to perform the 30-day follow-up assessment, as per standard of care

Exclusion criteria

  • Any planned concomitant procedures
  • Active anticoagulant treatment
  • Recurring hernia with mesh during primary hernia repair
  • Need for transversal abdominal release
  • Patients under corticosteroids or other immunosuppressive treatment
  • Loss of domain type of hernia
  • Previous incision extending from xiphoid process to pubic bone (= Median laparotomy M1 to M5)
  • M2 hernia extending to M1 and/or M4 hernia extending to M5
  • Ongoing intra-abdominal infection or septic state
  • Abdominal fistulae
  • History of major* abdominal or pelvic surgery

Treatment and study plan

ventral hernia repair

Device

Robotic-assisted incisional or primary ventral hernia repair with the DEXTER robotic surgery system

Primary outcomes

  1. Primary safety 0utcome

    Time frame: up to 30 days after surgery

    Occurrence of Clavien-Dindo grades III-V adverse events

  2. Primary efficacy outcome

    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

Acronym: RAVEN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
Jan 22, 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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