Bariatric Surgery CandidateNCT04506190
Prospective Robotic-assisted Revisional Bariatric Study
An observational study of Bariatric Surgery Candidate, run by Intuitive Surgical at 1 site in United States.
Trial summary
Very few studies have compared robotic-assisted (RRBS) versus laparoscopic revisional bariatric surgeries (LRBS). To date, there has not been a prospective study comparing the perioperative outcomes of patients undergoing robotic-assisted and laparoscopic revisional bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Revisional bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 30 Sep 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have had one previous bariatric surgery, are undergoing a revisional bariatric surgery applicable to this study, and who are deemed qualified by study inclusion and exclusion criteria.
Who may be able to join
- Subject is 18 years or older at the time of consent
- Subject has a history of prior bariatric surgery
- Subject's revisional procedure will be either laparoscopic revisional bariatric surgery (LRBS) or robotic-assisted revisional bariatric surgery (RRBS)
- Subject undergoes revisional bariatric surgery that is applicable to study
Who cannot join
- Subject is undergoing a primary bariatric procedure
- Subject has undergone more than one previous bariatric procedure
- Subject's revisional bariatric procedure is an emergent procedure
- Subject is contraindicated for general anesthesia or surgery
- Subject is unable to comply with the follow-up visit schedule
- Subject is pregnant or suspects pregnancy
- Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
- Subject belonging to other vulnerable population, e.g, prisoner or ward of the state
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multicenter Study to Evaluate the Perioperative Outcomes of Robotic-assisted Revisional Bariatric Surgery
Very few studies have compared robotic-assisted (RRBS) versus laparoscopic revisional bariatric surgeries (LRBS). To date, there has not been a prospective study comparing the perioperative outcomes of patients undergoing robotic-assisted and laparoscopic revisional bariatric surgery. This study aims to enroll patients undergoing RRBS and LRBS and evaluate the outcomes through 45 days, including the perioperative period. We hypothesize that RRBS may be associated with lower rates of perioperative outcomes.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Revisional bariatric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revisional bariatric surgeryProcedure or surgery
Subjects who undergo revisional bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted revisional bariatric surgery | Subjects who undergo robotic-assisted revisional bariatric surgery Receives: Procedure: Revisional bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of conversions
Conversions is defined as RRBS to LRBS or open revisional bariatric surgery, and LRBS to open revisional bariatric surgery
Measured: During the surgical procedure
Secondary outcomes (1)
Postoperative rate of anastomotic leak
Anastomotic leak is defined as a leak of luminal contents from a surgical join
Measured: 45 days after date of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Nov 2020
- Primary completion15 Mar 2022
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506190
- Sponsor's protocol ID
- ISI-dVBR-002
- Status last verified
- Apr 2025
- First submitted
- 5 Aug 2020
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All individual participant data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study to Evaluate the Perioperative Outcomes of Robotic-assisted Revisional Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04506190
- Acronym / sponsor ID
- ISI-dVBR-002
- Conditions
- Bariatric Surgery Candidate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 10 Aug 2020 (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.
Very few studies have compared robotic-assisted (RRBS) versus laparoscopic revisional bariatric surgeries (LRBS). To date, there has not been a prospective study comparing the perioperative outcomes of patients undergoing robotic-assisted and laparoscopic revisional bariatric surgery. This study aims to enroll patients undergoing RRBS and LRBS and evaluate the outcomes through 45 days, including the perioperative period. We hypothesize that RRBS may be associated with lower rates of perioperative outcomes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted revisional bariatric surgery | – | Procedure: Revisional bariatric surgerySubjects who undergo robotic-assisted revisional bariatric surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have had one previous bariatric surgery, are undergoing a revisional bariatric surgery applicable to this study, and who are deemed qualified by study inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- Subject is 18 years or older at the time of consent
- Subject has a history of prior bariatric surgery
- Subject's revisional procedure will be either laparoscopic revisional bariatric surgery (LRBS) or robotic-assisted revisional bariatric surgery (RRBS)
- Subject undergoes revisional bariatric surgery that is applicable to study
Key exclusion criteria (8 listed)
- Subject is undergoing a primary bariatric procedure
- Subject has undergone more than one previous bariatric procedure
- Subject's revisional bariatric procedure is an emergent procedure
- Subject is contraindicated for general anesthesia or surgery
- Subject is unable to comply with the follow-up visit schedule
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 |
|---|---|---|
| Revisional bariatric surgerySubjects who undergo revisional bariatric surgery | Procedure or surgery | Robotic-assisted revisional bariatric surgery |
Primary outcome
Rate of conversions
Time frame: During the surgical procedure
Conversions is defined as RRBS to LRBS or open revisional bariatric surgery, and LRBS to open revisional bariatric surgery
1 secondary outcome
Postoperative rate of anastomotic leak
Time frame: 45 days after date of procedure
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 13 Apr 2025.
- Individual participant dataSharing planned: Undecided. All individual participant data that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate, run by Intuitive Surgical at 1 site 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?
The sponsor lists 4 inclusion and 8 exclusion criteria. 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 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Rate of conversions (time frame: During the surgical procedure). 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 13 Apr 2025.