Assessment of an organ retraction device during bariatric surgery
Boehringer Laboratories Organ Retractor Device Study
This study is testing a special device used during weight loss surgery to see if it makes the surgery safer and easier for doctors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boehringer Labs LLC Industry-sponsored |
| Locations | 1 site (Raleigh, North Carolina) |
| Trial ID | NCT06754514 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and efficacy of a specialized organ retraction device used during primary robotic bariatric surgery. The device aims to improve surgical visibility and access while minimizing risks associated with liver retraction. Participants will be monitored for any adverse effects and the overall effectiveness of the device in facilitating the surgical procedure. The study is considered low risk as it involves patients already undergoing surgery.
Who should consider this trial
Good fit: Ideal candidates are individuals scheduled for minimally invasive primary bariatric surgery.
Not a fit: Patients with known liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could enhance surgical outcomes and reduce complications during bariatric surgery.
How similar studies have performed: While similar approaches have been explored, this specific device's efficacy in bariatric surgery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * undergoing minimally invasive primary bariatric surgery Exclusion Criteria: * known liver disease
Where this trial is running
Raleigh, North Carolina
- WakeMed Health & Hospitals — Raleigh, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Business Development
- Email: elagunilla@boehringerlabs.com
- Phone: 4849312338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.