TEMPO - OTTAVA Robotic System

Purpose of this Study

The OTTAVA Robotic System is a special machine that helps doctors do surgery through very small openings in the skin. The doctor controls the robot, and the robot moves the tools inside the body based on the doctors hand movements. A tiny camera helps the doctor see inside the body during the procedure. If you join this study, your surgery will be done with the OTTAVA Robotic System, and you will have three study visits.

Who Can Participate?

Eligibility

People can join this study if they are 18 years old or older. They must already be scheduled to have surgery to fix an inguinal hernia. They must also weigh less than 500 pounds.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

The purpose of this study is to learn if the OTTAVA Robotic System works safely during surgery. The study also wants to find out if surgery teams can use it to finish robotic assisted surgeries.

Locations

Duke Regional Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

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

Principal Investigator

Jacob
Greenberg

Protocol Number

PRO00119435

NCT ID

NCT07298317

Enrollment Status

Open to Enrollment