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NCT Number: NCT07298317

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

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).

Recruiting

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Key information

Conditions

Hernia, Inguinal Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampa General Hospital, Tampa, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OTTAVA Robotic System

Device

Participants will undergo the IHR procedure using OTTAVA Robotic System.

Primary outcomes

  1. Number of Participants Achieving Procedure Completion Without Conversion

    Time frame: Intraoperative

    Number of participants achieving procedure completion without conversion will be reported.

  2. 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

    The Clavien-Dindo classification for surgical complications provides a standardized, reproducible means for describing surgical complications based on described therapy for treatment. Clavien-Dindo grade III complications include those complications that require surgical, endoscopic, or radiological intervention. The interventions that are not given under general anesthesia are grade III A and the interventions given under general anesthesia are grade III B complications.

Secondary outcomes

  1. Number of Participants with Adverse Events (AE) through 30 Days Post-Procedure

    Time frame: Up to 30 days post-procedure

    An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.

  2. Total Operative Time

    Time frame: Intraoperative

    Total procedure time is defined by the time taken for the procedure, that is, from skin incision to skin closure.

  3. Number of Participants Needing Blood Transfusion

    Time frame: Intraoperative, Up to 30 days post-procedure

    Number of participants needing blood transfusions will be reported.

  4. Number of Units of Blood Transfusion

    Time frame: Intraoperative, Up to 30 days post-procedure

    Number of units of blood transfusion will be reported.

  5. Number of Participants Experiencing Device Malfunction

    Time frame: Intraoperative

    Device malfunction is defined as a failure of an investigational medical device to perform in accordance with its intended purpose when used in accordance with the instructions for use or clinical investigation plan.

  6. Length of Hospital Stay

    Time frame: Intraoperative, Up to 30 days post-procedure

    The length of hospital stay from the date of procedure until discharge will be reported.

  7. Number of Participants with Hospital Readmission

    Time frame: Up to 30 days post-procedure

    Number of participants getting admitted to hospital again after discharge within 30 days post-procedure will be reported.

  8. Number of Participants with Reoperations

    Time frame: Up to 30 days post-procedure

    Number of participants with reoperations including any procedures performed within 30 days that are directly related to the index procedure will be reported.

  9. Mortality

    Time frame: Intraoperative, Up to 30 days post-procedure

    Number of mortalities will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Damaris Pederson, MPH

CONTACT

[email protected]

1 619 708 2607

Dominic Papandria, MD

CONTACT

[email protected]

16509226723

Sponsors and collaborators

Lead sponsor

Auris Health, Inc.

Industry

Registry information

Official study title

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

Acronym: TEMPO

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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