Safety and Performance of the OTTAVA System in Participants Undergoing Inguinal Hernia Repair

Part of paid clinical trials in Tampa, Florida.

Sponsor
Auris Health, Inc.
Study ID
NCT07298317
Status
Recruiting
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Conditions

  • Hernia, Inguinal

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OTTAVA Robotic System — DEVICE
    Participants will undergo the IHR procedure using OTTAVA Robotic System.

Study Details

The purpose of this study is to assess safety and performance of the OTTAVA System, through 30 days postoperative, in participants undergoing robotic-assisted inguinal hernia repair (IHR).

Key Dates

First listed
Dec 23, 2025
Start date
Mar 11, 2026
Status verified
Aug 2026
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OTTAVA Robotic System
    Participants scheduled to undergo a non-emergent inguinal hernia repair (IHR) procedure, and who meet all study eligibility criteria, will be enrolled to receive the IHR procedure with OTTAVA Robotic System. After the hospital discharge, participants will undergo follow-up visits according to the institution's standard of care and complete a final follow-up visit at 30 days post-procedure.

Primary Outcome Measure

Number of Participants Achieving Procedure Completion Without Conversion [ Time Frame: Intraoperative ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Tampa General HospitalTampaFlorida33606-
Indiana University North HospitalCarmelIndiana46032-
Duke Regional HospitalDurhamNorth Carolina27704-
The University of Texas Health Science Center at HoustonHoustonTexas77030-

Find similar trials in Tampa, FL

By research site
Tampa General Hospital· Tampa, FLIndiana University North Hospital· Carmel, INDuke Regional Hospital· Durham, NCThe University of Texas Health Science Center at Houston· Houston, TX

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