Robotic Minimally Invasive Inguinal Hernia Repair With Dexter

NCT ID: NCT05873582

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-02

Study Completion Date

2023-10-23

Brief Summary

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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.

Detailed Description

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Conditions

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Inguinal Hernia Repair

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Robotic-assisted inguinal hernia repair

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

Intervention Type DEVICE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Confinis

INDUSTRY

Sponsor Role collaborator

Distalmotion SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier de Saintes

Saintes, , France

Site Status

UKSH Kiel

Kiel, , Germany

Site Status

Kantonspital Winterthur

Winterthur, , Switzerland

Site Status

Countries

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France Germany Switzerland

Other Identifiers

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2023-01

Identifier Type: -

Identifier Source: org_study_id

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