Technology Evaluation in a Multi-Center Study of Safety and Performance of the OTTAVA System
Auris Health, Inc.
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
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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 concomit…
Interventions
- DeviceOTTAVA Robotic System
Participants will undergo the IHR procedure using OTTAVA Robotic System.
Locations (4)
- Tampa General HospitalTampa, Florida
- Indiana University North HospitalCarmel, Indiana
- Duke Regional HospitalDurham, North Carolina
- The University of Texas Health Science Center at HoustonHouston, Texas