Discrete(TM) Safety Clinical Trial GLAD-01

Not Applicable

Completed

• Conditions: Safety and Tolerability in Healthy Volunteers
• Interventions: Device: Discrete(TM); Other: Control Lactated Ringer's Solution (Control LRS)

• Registration Number: NCT04034784
• Lead Sponsor: ARC Medical Devices Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-26
• Study Start: 2020-06-18
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Discrete(TM)	Discrete(TM)	Intraperitoneal injection
Control Lactated Ringer's Solution (Control LRS)	Control Lactated Ringer's Solution (Control LRS)	Intraperitoneal injection

Primary Outcome Measures

Name	Time	Method
Safety as evaluated by assessment of adverse events in treatment and control group	Up to 10 days post application	The rate of adverse events will be compared in treatment and control groups

Secondary Outcome Measures

Name	Time	Method
Participant recovery	Post application to 10 days post application	Participant recovery after Discrete(TM) application

Trial Locations

Locations (1)

Clinical trial site; 🇨🇦 Toronto, Canada