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Recruiting NCT07298317

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

No phase Interventional Hernia, Inguinal

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: OTTAVA Robotic System.
Who it may be relevant to
Registry conditions: Hernia, Inguinal. 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 →

Unsure about the terms? Read our patient guide →

Official title

Technology Evaluation in a Multi-Center Study of Safety and Performance of the OTTAVA System

Overview

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).

Interventions

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

Primary outcome measures

  • Number of Participants Achieving Procedure Completion Without Conversion [Time frame: Intraoperative]
  • Number of Participants Experiencing Intraoperative and Postoperative Device or Procedure-Related Complications Greater than or Equal to (>=) Clavien-Dindo Grade III through 30 Days Post-Procedure [Time frame: Intraoperative through 30 days post-procedure]
Secondary outcome measures (9)
  • Number of Participants with Adverse Events (AE) through 30 Days Post-Procedure [Time frame: Up to 30 days post-procedure]
  • Total Operative Time [Time frame: Intraoperative]
  • Number of Participants Needing Blood Transfusion [Time frame: Intraoperative, Up to 30 days post-procedure]
  • Number of Units of Blood Transfusion [Time frame: Intraoperative, Up to 30 days post-procedure]
  • Number of Participants Experiencing Device Malfunction [Time frame: Intraoperative]
  • Length of Hospital Stay [Time frame: Intraoperative, Up to 30 days post-procedure]
  • Number of Participants with Hospital Readmission [Time frame: Up to 30 days post-procedure]
  • Number of Participants with Reoperations [Time frame: Up to 30 days post-procedure]
  • Mortality [Time frame: Intraoperative, Up to 30 days post-procedure]

Eligibility criteria

Inclusion criteria

Subjects must satisfy all inclusion criteria to be eligible for enrollment:

  • Willing and able to provide informed consent
  • A minimum of 22 years old at time of consent
  • Scheduled for elective primary inguinal hernia repair
  • American Society of Anesthesiologists (ASA) classification I, II, or III
  • Weight less than 227 kilograms (500 pounds)

Exclusion criteria

Subjects who meet any of the exclusion criteria may not be enrolled:

  • Physician determination, including intraoperative finding, that subject is a poor candidate for robotic surgery
  • Scheduled concomitant surgical procedure, other than lysis of adhesions, groin hernia repair, or umbilical or epigastric hernia repair not requiring mesh
  • Previous ipsilateral minimally invasive inguinal hernia repair (laparoscopic or robotic)
  • Previous radical prostatectomy procedure or pelvic irradiation
  • Hernia with significant scrotal involvement
  • Emergency surgery
  • Enrolled in another investigational study that may confound the results of this study
  • Currently pregnant or will be pregnant at time of procedure
  • Subject from a vulnerable population, including anyone unable to adequately provide informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Tampa General Hospital — Tampa
  • Indiana University North Hospital — Carmel
  • Duke Regional Hospital — Durham
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07298317 · EDS202402

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗