Safety and Performance of the OTTAVA System in Participants Undergoing Inguinal Hernia Repair
ConditionHernia, Inguinal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorAuris Health, Inc.
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- OTTAVA Robotic System
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov