Recruiting

Observational Study

Sponsor:

Boehringer Labs LLC

Code:

NCT06754514

Conditions

Liver Retraction During Bariatric Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

liver retraction

Study Details

Brief 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.

Conditions

Liver Retraction During Bariatric Surgery

Study ID

NCT06754514

Start date

Mar 14, 2024

Status verified date

Dec, 2024

Completion date

Jan, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • undergoing minimally invasive primary bariatric surgery

Exclusion Criteria:

  • known liver disease

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Interventions

liver retraction

A different way to lift the liver during bariatric surgery

Primary outcome measure

  • Ease of use and Feasibility [ Time Frame: During surgery ]

Central Contacts and Locations

Central contacts

Business Development

4849312338elagunilla@boehringerlabs.com

Locations

WakeMed Health & Hospitals

Recruiting

Raleigh, North Carolina, United States, 27610

Contacts

Clinical Research Manager

919-350-8000ladaniel@wakemed.org

More Information

Sponsor

Boehringer Labs LLC

Last update posted

Jan 1, 2025

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boehringer Labs LLC on 2025-01-01.