Robotic Minimally Invasive Ventral Hernia Repair With DEXTER | NCT07071740

Studies
Robotic Minimally Invasive Ventral Hernia Repair With DEXTER

NCT07071740

Sponsor

Distalmotion SA

Status

Completed

Last Update Posted

Jan 22, 2026Actual

Enrollment

33Actual

Phase

Not provided

Conditions

Ventral Hernia Repair

Interventions

ventral hernia repair

Countries

Austria
France
Germany
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 11, 2025Actual

Primary Completion Date

Jan 15, 2026Actual

Completion Date

Jan 15, 2026Actual

First Submitted Date

Jul 8, 2025

First Submission Date that Met QC Criteria

Jul 8, 2025

First Posted Date

Jul 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2026

Last Update Posted Date

Jan 22, 2026Actual

Name	Class
Confinis	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ventral hernia repair	Device	Robotic-assisted incisional or primary ventral hernia repair with the DEXTER robotic surgery system

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients undergoing incisional or primary ventral hernia repair

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allgemein öffentliches Krankenhaus Spittal/Drau		Spittal an der Drau		9800	Austria
GH Saintes - Saint-Jean-d'Angély Site de Saintes