Recruiting NCT07181876
Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: inguinal hernia repair.
- Who it may be relevant to
- Registry conditions: Inguinal Hernia Repair. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device inguinal hernia repair
Robotic-assisted inguinal hernia repair with the DEXTER robotic surgery system
Primary outcome measures
- Primary safety outcome [Time frame: up to 30 days after surgery]
- Primary efficacy outcome [Time frame: Intraoperative]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 2 centers
- Northtowns Ambulatory Surgical Center (NASC) — Buffalo
- Memorial Hermann-Texas Medical Center - UT Health Houston — Houston
Identifiers
NCT: NCT07181876 · 2025-03