NCT05873582

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
3 countries

3 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

First Submitted

Initial submission to the registry

May 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

June 2, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

May 15, 2023

Last Update Submit

January 3, 2024

Conditions

Inguinal Hernia Repair

Outcome Measures

Primary Outcomes (2)

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

    perioperatively up to 30 days

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

    intraoperative

Interventions

Robotic-assisted inguinal hernia repairDEVICE

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

Eligibility Criteria

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

adult patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Hospitalier de Saintes

Saintes, France

Location

UKSH Kiel

Kiel, 24105, Germany

Location

Kantonspital Winterthur

Winterthur, 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

May 15, 2023

First Posted

May 24, 2023

Study Start

June 2, 2023

Primary Completion

October 23, 2023

Study Completion

October 23, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)CH(1)FR(1)