Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System

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

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-26

Study Completion Date

2029-12-31

Brief Summary

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The purpose of this post-market, observational study is to collect data under anticipated conditions of use that demonstrates that DEXTER performs as intended in the intended patient population, including a variety of representative disease etiologies and demographic groups.

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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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inguinal hernia repair

Robotic-assisted inguinal hernia repair with the DEXTER robotic surgery system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is ≥ 22 years of age at time of enrollment/consent
* Subject is indicated for and planned to undergo robot-assisted and laparoscopic surgery for unilateral or bilateral inguinal hernia repair
* Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form

Exclusion Criteria

* Subject with any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments and/or general non-procedure specific contraindications to endoscopic surgery including bleeding diathesis and pregnancy
* Subject is participating in another clinical investigation at the time of enrollment or planned participation at any time during this clinical study
* Subject has a known or suspected medical condition that, in the opinion of the Investigator, may put the subject at risk for participation in this clinical study

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No