ClinicalTrials.gg
CompletedNCT06709261FORTEUpdated Sep 28, 2026

Safety and Performance of the OTTAVA Robotic System

An interventional study of OTTAVA Robotic System in Obesity, sponsored by Auris Health, Inc.. Completed at 6 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Auris Health, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2025, 1 year ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 35 studies in Obesity by Johnson & Johnson — none open to participants now, none under way, none of them phase 3. Obesity · Johnson & Johnson.

Enrollment
24th of 31
32 · median 113
Started
2025
the only one that year
No phase
9 of 35
none open now
Registered
35th of 35
by date

Among the 35 studies in Obesity by Johnson & Johnson, this one is the 24th largest by enrollment of the 31 interventional ones that give a count, is the only one that started in 2025, is one of 9 with no phase, and was the 35th registered.

Obesity

11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.

Browse Obesity studies →

Open to participants now

None of the 35 studies in Obesity by Johnson & Johnson is open now. The open studies under Obesity, anywhere →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 166 take children under 18; 488 take healthy volunteers.

This study: 21 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 35 studies in Obesity by Johnson & Johnson as a file.
02

Study 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.

03

Conditions studied

  • Obesity

Browse trials for

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Criteria for Inclusion:

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

Criteria for Exclusion:

  1. Surgeon determination that there is a medical condition, that makes surgery too risky, including intraoperative finding;
  2. Concomitant surgical procedure including cholecystectomy (hiatal hernia repair up to 5 cm and adhesiolysis allowed);
  3. Upper abdominal surgery within two years prior to enrollment (prior laparoscopic cholecystectomy allowed);
  4. Evidence of hiatal hernia >5 cm (preoperative/intraoperative);
  5. Enrolled in another study that may confound the results of this study;
  6. Emergency surgery;
  7. Active pregnancy; or
  8. Subject from a vulnerable population, including anyone unable to adequately provide informed consent.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    OTTAVA Robotic System

    Procedure with the OTTAVA Robotic System

    Device: OTTAVA Robotic System

Interventions

  • DeviceOTTAVA Robotic System

    Procedure with the OTTAVA Robotic System

06

What researchers measure

Primary outcomes

  1. Procedure completion without conversion to open surgery

    Time frame: Procedure day

  2. Occurrence of intraoperative and postoperative device- or procedure-related complications

    Time frame: Through 30 days post-procedure

Secondary outcomes

  1. Occurrence of all adverse events

    Time frame: Through 30 days post-procedure

  2. Total operative time

    Time frame: Procedure day

  3. Estimated blood loss

    Time frame: Procedure day

  4. Occurrence of blood transfusion

    Time frame: Procedure day

  5. Device malfunction details

    Time frame: Procedure day

  6. Length of hospital stay

    Time frame: Hospital stay, assessed up to 30 days

  7. Hospital readmission

    Time frame: Through 30 days

  8. Reoperation

    Time frame: Through 30 days

  9. Anastomotic leak

    Time frame: Through 30 days

  10. Anastomotic stricture

    Time frame: Through 30 days

  11. Mortality

    Time frame: Through 30 days

07

Study locations

6 sites
  • Orlando Health
    Orlando, Florida 32806, United States
  • University of South Florida Tampa General Hospital
    Tampa, Florida 33606, United States
  • IU Health North Hospital
    Indianapolis, Indiana 46302, United States
  • NYU Long Island
    Mineola, New York 11501, United States
  • Duke Regional Hospital
    Durham, North Carolina 27704, United States
  • UT Health Houston and Memorial Hermann TMC
    Bellaire, Texas 77401, United States
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2025 to primary completion in Oct 2025, 8 months.

Of 163 industry-sponsored interventional studies with no phase under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's 8 months is below that.

Counting every sponsor, half of 3,846 studies reached it within 22 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2024
First posted
Nov 29, 2024
StartActual
Feb 5, 2025
Primary completionActual
Oct 20, 2025
CompletionActual
Oct 20, 2025
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06709261
Lead sponsor
Auris Health, Inc.
Responsible party
Sponsor
First posted
Nov 29, 2024
Start date
Feb 5, 2025
Primary completion
Oct 20, 2025
Completion
Oct 20, 2025
Last update
Sep 28, 2026

Study contacts

Erik Wilson, MD
principal investigator · Memorial Hermann Texas Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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