Safety and Performance of the OTTAVA Robotic System

NCT06709261 | Completed FDA Device

• 1 other identifier: EDS-2022-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 6

Brief Summary

This study assesses safety and performance of the OTTAVA Robotic System, through 30 days postoperative, in subjects undergoing robotic-assisted Roux-en-Y Gastric Bypass (RYGB) procedure.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Procedure completion without conversion to open surgery

  Procedure day

• Occurrence of intraoperative and postoperative device- or procedure-related complications

  Through 30 days post-procedure

Secondary Outcomes (11)

• Occurrence of all adverse events

  Through 30 days post-procedure

• Total operative time

  Procedure day

• Estimated blood loss

  Procedure day

• Occurrence of blood transfusion

  Procedure day

• Device malfunction details

  Procedure day

Study Arms (1)

OTTAVA Robotic System

EXPERIMENTAL

Procedure with the OTTAVA Robotic System

Device: OTTAVA Robotic System

Interventions

OTTAVA Robotic System DEVICE

Procedure with the OTTAVA Robotic System

OTTAVA Robotic System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent;
• Scheduled for an elective primary RYGB surgical procedure;
• American Society of Anesthesiologists classification ≤ ASA III;
• Body habitus such that the procedure can be safely completed with OTTAVA Robotic System;
• Body weight \<500 lb (227 kg);
• Patient presenting with class 2 or 3 obesity (BMI ≥ 35), regardless of comorbidities, or obesity with health risk satisfying 2022 ASMBS/IFSO indications for bariatric surgery; and
• A minimum of 21 years of age (at time of consent).

You may not qualify if:

• Surgeon determination that there is a medical condition, that makes surgery too risky, including intraoperative finding;
• Concomitant surgical procedure including cholecystectomy (hiatal hernia repair up to 5 cm and adhesiolysis allowed);
• Upper abdominal surgery within two years prior to enrollment (prior laparoscopic cholecystectomy allowed);
• Evidence of hiatal hernia \>5 cm (preoperative/intraoperative);
• Enrolled in another investigational study that may confound the results of this study;
• Emergency surgery;
• Active pregnancy; or
• Subject from a vulnerable population, including anyone unable to adequately provide informed consent.

Sponsors & Collaborators

• Auris Health, Inc.: lead

Study Sites (6)

Orlando Health

Orlando, Florida, 32806, United States

Location

University of South Florida Tampa General Hospital

Tampa, Florida, 33606, United States

Location

IU Health North Hospital

Indianapolis, Indiana, 46302, United States

Location

NYU Long Island

Mineola, New York, 11501, United States

Location

Duke Regional Hospital

Durham, North Carolina, 27704, United States

Location

UT Health Houston and Memorial Hermann TMC

Bellaire, Texas, 77401, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erik Wilson, MD

  Memorial Hermann Texas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 29, 2024
• Study Start: February 5, 2025
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: September 28, 2026

Record last verified: 2026-09

Locations

US (6)