Bariatric Surgery CandidateNCT06282094
ViSiGi LUX Bariatric Sizing and Calibration System
An observational study of Bariatric Surgery Candidate, run by Boehringer Labs LLC at 1 site in United States.
Trial summary
This study investigates the new ViSiGi LUX. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bariatric Surgery Candidate
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2024to Mar 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing gastric or bariatric procedures.
Who may be able to join
- 18 years or older
- able to consent
- candidate for robotic bariatric surgery
Who cannot join
- esophageal stricture that does not allow passage of the device
- conditions that would preclude gastric or bariatric surgical procedures
- pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
WellSpan
York, Pennsylvania, 17405
Faiz Shariff
About this study
Official title: ViSiGi LUX Bariatric Sizing and Calibration System Usability Study
This study investigates the new ViSiGi LUX.
Read the detailed description
ViSiGi is used during numerous gastric and bariatric procedures. The new device, ViSiGi LUX functions as the FDA-cleared ViSiGi but has the added visualization of NIR lights.
- Conditions
- Bariatric Surgery Candidate
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Feedback
The physician provides feedback and comments on the usability of the device. The physician will rate the device on a Likert scale. 1-7 higher score is better
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start26 Jan 2024
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Labs LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282094
- Sponsor's protocol ID
- LUX
- Status last verified
- Mar 2024
- First submitted
- 12 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ViSiGi LUX Bariatric Sizing and Calibration System Usability Study
- ClinicalTrials.gov ID
- NCT06282094
- Acronym / sponsor ID
- LUX
- Conditions
- Bariatric Surgery Candidate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Boehringer Labs LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 28 Feb 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 investigates the new ViSiGi LUX.
Detailed description
ViSiGi is used during numerous gastric and bariatric procedures. The new device, ViSiGi LUX functions as the FDA-cleared ViSiGi but has the added visualization of NIR lights.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing gastric or bariatric procedures.
Key inclusion criteria (3 listed)
- 18 years or older
- able to consent
- candidate for robotic bariatric surgery
Key exclusion criteria (3 listed)
- esophageal stricture that does not allow passage of the device
- conditions that would preclude gastric or bariatric surgical procedures
- pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physician Feedback
Time frame: 6 months
The physician provides feedback and comments on the usability of the device. The physician will rate the device on a Likert scale. 1-7 higher score is better
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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.
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 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Lagunilla (4849312338, elagunilla@boehringerlabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician Feedback (time frame: 6 months). 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 Mar 2024.