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Completed
NCT07298317
Safety and Performance of the OTTAVA System in Participants Undergoing Inguinal Hernia Repair
Conditions: Hernia, Inguinal
Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Auris Health, Inc.
Location: Tampa General Hospital Tampa Florida
Summary
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).
Eligibility Criteria
Inclusion Criteria
Subjects must satisfy all inclusion criteria to be eligible for enrollment:
1. Willing and able to provide informed consent
2. A minimum of 22 years old at time of consent
3. Scheduled for elective primary inguinal hernia repair
4. American Society of Anesthesiologists (ASA) classification I, II, or III
5. Weight less than 227 kilograms (500 pounds)
Exclusion Criteria
Subjects who meet any of the exclusion criteria may not be enrolled:
1. Physician determination, including intraoperative finding, that subject is a poor candidate for robotic surgery
2. Scheduled concomitant surgical procedure, other than lysis of adhesions, groin hernia repair, or umbilical or epigastric hernia repair not requiring mesh
3. Previous ipsilateral minimally invasive inguinal hernia repair (laparoscopic or robotic)
4. Previous radical prostatectomy procedure or pelvic irradiation
5. Hernia with significant scrotal involvement
6. Emergency surgery
7. Enrolled in another investigational study that may confound the results of this study
8. Currently pregnant or will be pregnant at time of procedure
9. Subject from a vulnerable population, including anyone unable to adequately provide informed consent.
Source: ClinicalTrials.gov (NCT07298317). StuddyBuddy aggregates publicly available trial information.