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CompletedNCT05873582RAS-AheadUpdated Jan 5, 2024

Robotic Minimally Invasive Inguinal Hernia Repair With Dexter

An observational study in Inguinal Hernia Repair, sponsored by Distalmotion SA. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-05.

Sponsored by Distalmotion SA · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair.

02

Conditions studied

  • Inguinal Hernia Repair
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 50 is below the median of 120 across 327 observational studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Distalmotion SA is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

adult patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair

Inclusion criteria

  • Aged > 18 years
  • Patients planned to undergo elective robot-assisted and laparoscopic surgery for primary unilateral or bilateral inguinal hernia repair using one camera port, two ports for the manipulating instruments, and additional ports as needed.
  • Able to provide Informed Consent according to local regulation

Exclusion criteria

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 or under legal guardianship
  • Participation in another interventional clinical trial
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Interventions

  • DeviceRobotic-assisted inguinal hernia repair

    Primary transperitoneal unilateral or bilateral inguinal hernia repair with the Dexter robotic system

06

What researchers measure

Primary outcomes

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

    Time frame: perioperatively up to 30 days

  2. Performance: successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach

    Time frame: intraoperative

07

Study locations

3 sites
  • Centre Hospitalier de Saintes
    Saintes, France
  • UKSH Kiel
    Kiel, 24105, Germany
  • Kantonspital Winterthur
    Winterthur, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05873582
Lead sponsor
Distalmotion SA
Collaborators
confinis AG
Responsible party
Sponsor
First posted
May 24, 2023
Start date
Jun 2, 2023
Primary completion
Oct 23, 2023
Completion
Oct 23, 2023
Last update
Jan 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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