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Discrete(TM) Safety Clinical Trial GLAD-01

NCT04034784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-06-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • ARC Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Chris Springate, PhD · ARC Medical Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04034784 on ClinicalTrials.gov