NCT07071740

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

July 8, 2025

Last Update Submit

January 21, 2026

Conditions

Ventral Hernia Repair

Outcome Measures

Primary Outcomes (2)

  • Primary safety 0utcome

    Occurrence of Clavien-Dindo grades III-V adverse events

    up to 30 days after surgery

  • Primary efficacy outcome

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

    Intraoperative

Interventions

ventral hernia repairDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing incisional or primary ventral hernia repair

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Allgemein öffentliches Krankenhaus Spittal/Drau

Spittal an der Drau, 9800, Austria

Location

GH Saintes - Saint-Jean-d'Angély Site de Saintes

Saintes, 17100, France

Location

Artemed Klinikum München Süd

München, 81379, Germany

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

Hirslanden Klinik Zürich

Zurich, Switzerland

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2025

First Posted

July 17, 2025

Study Start

June 11, 2025

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations

DE(1)CH(2)AU(1)FR(1)