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Mystery device trial underway – details kept secret

NCT ID NCT06709261

Knowledge-focused Sponsor: Auris Health, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 7 times

Summary

This clinical trial is testing a medical device that has not been approved or cleared by the U.S. FDA. The specific purpose, who can join, and how the device works are not publicly available. Because key details are withheld, it is not possible to describe the expected benefits or risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

32 people

The number who actually took part.

Started

Feb 2025

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Criteria for Inclusion: 1. Willing and able to provide informed consent; 2. Scheduled for an elective primary RYGB surgical procedure; 3. American Society of Anesthesiologists 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 (BMI ≥ 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 investigational 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.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

Contacts and locations

Locations

  • Duke Regional Hospital

    Durham, North Carolina, 27704, United States

  • IU Health North Hospital

    Indianapolis, Indiana, 46302, United States

  • NYU Long Island

    Mineola, New York, 11501, United States

  • Orlando Health

    Orlando, Florida, 32806, United States

  • UT Health Houston and Memorial Hermann TMC

    Bellaire, Texas, 77401, United States

  • University of South Florida Tampa General Hospital

    Tampa, Florida, 33606, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.