ObesityFORTENCT06709261
Safety and Performance of the OTTAVA Robotic System
A study testing OTTAVA Robotic System in people with Obesity, run by Auris Health, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- OTTAVA Robotic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 6 sitesUnited States
- Study dates
- 5 Feb 2025to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Criteria for Inclusion:
- 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).
Criteria for Exclusion:
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
UT Health Houston and Memorial Hermann TMC
Bellaire, Texas, 77401
Duke Regional Hospital
Durham, North Carolina, 27704
IU Health North Hospital
Indianapolis, Indiana, 46302
NYU Long Island
Mineola, New York, 11501
Orlando Health
Orlando, Florida, 32806
University of South Florida Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: EDS-2022-01: Safety and Performance of the OTTAVA™ Robotic System: A Prospective, Multi-Center Evaluation (FORTE)
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
- Being tested
- OTTAVA Robotic System
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTTAVA Robotic SystemDevice
Procedure with the OTTAVA Robotic System
| Study group | Role | What they receive |
|---|---|---|
| OTTAVA Robotic System | Experimental | Procedure with the OTTAVA Robotic System Receives: Device: OTTAVA Robotic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure completion without conversion to open surgery
Measured: Procedure day
Occurrence of intraoperative and postoperative device- or procedure-related complications
Measured: Through 30 days post-procedure
Secondary outcomes (11)
Occurrence of all adverse events
Measured: Through 30 days post-procedure
Total operative time
Measured: Procedure day
Estimated blood loss
Measured: Procedure day
Occurrence of blood transfusion
Measured: Procedure day
Device malfunction details
Measured: Procedure day
Length of hospital stay
Measured: Hospital stay, assessed up to 30 days
Hospital readmission
Measured: Through 30 days
Reoperation
Measured: Through 30 days
Anastomotic leak
Measured: Through 30 days
Anastomotic stricture
Measured: Through 30 days
Mortality
Measured: Through 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start5 Feb 2025
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auris Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erik Wilson, MD, Principal investigator, Memorial Hermann Texas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709261
- Sponsor's protocol ID
- EDS-2022-01
- Other IDs
- EDS-2022-01
- Acronym
- FORTE
- Status last verified
- Sep 2026
- First submitted
- 21 Nov 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EDS-2022-01: Safety and Performance of the OTTAVA™ Robotic System: A Prospective, Multi-Center Evaluation (FORTE)
- ClinicalTrials.gov ID
- NCT06709261
- Acronym / sponsor ID
- FORTE / EDS-2022-01
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Auris Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OTTAVA Robotic System | Experimental | Device: OTTAVA Robotic SystemProcedure with the OTTAVA Robotic System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTTAVA Robotic SystemProcedure with the OTTAVA Robotic System | Device | OTTAVA Robotic System |
Primary outcome
Procedure completion without conversion to open surgery
Time frame: Procedure day
Occurrence of intraoperative and postoperative device- or procedure-related complications
Time frame: Through 30 days post-procedure
11 secondary outcomes
Occurrence of all adverse events
Time frame: Through 30 days post-procedure
Total operative time
Time frame: Procedure day
Estimated blood loss
Time frame: Procedure day
Occurrence of blood transfusion
Time frame: Procedure day
Device malfunction details
Time frame: Procedure day
Length of hospital stay
Time frame: Hospital stay, assessed up to 30 days
Hospital readmission
Time frame: Through 30 days
Reoperation
Time frame: Through 30 days
Anastomotic leak
Time frame: Through 30 days
Anastomotic stricture
Time frame: Through 30 days
Mortality
Time frame: Through 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Wilson, MD principal investigator
Memorial Hermann Texas Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTTAVA Robotic System in people with Obesity, run by Auris Health, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure completion without conversion to open surgery (time frame: Procedure day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.