NCT04034784

Discrete(TM) Safety Clinical Trial GLAD-01

Controlled, Single Ascending Volume Clinical Trial to Evaluate the Safety and Tolerability of the Adhesion Reduction Medical Device Discrete(TM) in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: ARC Medical Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study will assess the safety and tolerability of a new liquid anti-adhesion device, Discrete(TM), in healthy volunteers, in order to determine the best volume of Discrete(TM) to go forward into clinical efficacy research. The clinical trial will progress in accordance with first-in-human study guidance from the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA). It will be conducted as a randomized, controlled, double-blinded, single ascending volume, single-center, interventional safety trial. Participants will remain blinded to treatment until end of clinical trial. A maximum of 7 cohorts will be studied to assess maximum tolerated volume of investigational medical device compared with Control Lactated Ringer's solution (LRS) administered intraperitoneally. The trial will commence with a low volume and progress in a sequential, stepwise volume-escalating schema until defined maximum tolerated volume criteria are met. Following determination of the maximum tolerated volume, it is anticipated that up to 2 additional cohorts will be enrolled, wherein all participants will also receive a single standard dose of a commonly used anticoagulant as used in surgeries. A maximum of 81 participants will be enrolled. Eligible and consented adult men and women will be sequentially enrolled within each cohort at a ratio of 6 participants on Discrete(TM) to 3 participants on Control LRS. Participants will be followed for up to 10 days after intraperitoneal application. An independent Data and Safety Monitoring Committee will closely review safety in the clinical trial.

Conditions

• Safety and Tolerability in Healthy Volunteers

Interventions

Type	Name	Description
DEVICE	Discrete(TM)	A designated volume of Discrete(TM) (according to cohort) is applied intraperitoneally
OTHER	Control Lactated Ringer's Solution (Control LRS)	A designated volume of LRS (according to cohort and equivalent to volume of Discrete(TM)) is applied intraperitoneally

Timeline

• Start date: 2020-06-18
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2019-07-26
• Last updated: 2021-06-09

Locations

1 site across 1 country: Canada