Liver Retraction During Bariatric SurgeryNCT06754514
Organ Retractor Device Study
An observational study of Liver Retraction During Bariatric Surgery, run by Boehringer Labs LLC at 1 site in United States.
Trial summary
This study aims to assess the safety and efficacy of an organ retraction device. The study is low risk as it is only being used in patients already undergoing primary robotic bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Retraction During Bariatric Surgery
- What is being tested?
- liver retraction
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2024to Jan 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Identified by doctor
Who may be able to join
- undergoing minimally invasive primary bariatric surgery
Who cannot join
- known liver disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610
Clinical Research Manager, 919-350-8000, ladaniel@wakemed.org
About this study
Official title: Boehringer Laboratories Organ Retractor Device Study
This study aims to assess the safety and efficacy of an organ retraction device. The study is low risk as it is only being used in patients already undergoing primary robotic bariatric surgery.
- Being tested
- liver retraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver retractionDevice
A different way to lift the liver during bariatric surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of use and Feasibility
After surgery, surgeons will be asked a series of questions and asked to rank the ease of use on a scale of 1-10
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start14 Mar 2024
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Retraction During Bariatric SurgeryStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Boehringer Labs LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754514
- Sponsor's protocol ID
- Retractor-01
- Status last verified
- Dec 2024
- First submitted
- 16 Oct 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boehringer Laboratories Organ Retractor Device Study
- ClinicalTrials.gov ID
- NCT06754514
- Acronym / sponsor ID
- Retractor-01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Boehringer Labs LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 1 Jan 2025 (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 aims to assess the safety and efficacy of an organ retraction device. The study is low risk as it is only being used in patients already undergoing primary robotic bariatric surgery.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Identified by doctor
Key inclusion criteria (1 listed)
- undergoing minimally invasive primary bariatric surgery
Key exclusion criteria (1 listed)
- known liver disease
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 |
|---|---|---|
| liver retractionA different way to lift the liver during bariatric surgery | Device | – |
Primary outcome
Ease of use and Feasibility
Time frame: During surgery
After surgery, surgeons will be asked a series of questions and asked to rank the ease of use on a scale of 1-10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: No
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.
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 Liver Retraction During Bariatric Surgery, run by Boehringer Labs LLC 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Business Development (4849312338, elagunilla@boehringerlabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of use and Feasibility (time frame: During surgery). 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 1 Jan 2025.