Discrete(TM) Safety Clinical Trial GLAD-01

NCT04034784 | Completed DMC

• 2 other identifiers: ARCMD-GLAD-01GLAD-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety and Tolerability in Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Safety as evaluated by assessment of adverse events in treatment and control group

  The rate of adverse events will be compared in treatment and control groups

  Up to 10 days post application

Secondary Outcomes (1)

• Participant recovery

  Post application to 10 days post application

Study Arms (2)

Discrete(TM)

EXPERIMENTAL

Intraperitoneal injection

Device: Discrete(TM)

Control Lactated Ringer's Solution (Control LRS)

SHAM COMPARATOR

Intraperitoneal injection

Other: Control Lactated Ringer's Solution (Control LRS)

Interventions

Discrete(TM) DEVICE

A designated volume of Discrete(TM) (according to cohort) is applied intraperitoneally

Discrete(TM)

Control Lactated Ringer's Solution (Control LRS) OTHER

A designated volume of LRS (according to cohort and equivalent to volume of Discrete(TM)) is applied intraperitoneally

Control Lactated Ringer's Solution (Control LRS)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Understand and be able to follow the requirements of the protocol including signing and dating an REB approved Informed Consent Form prior to undergoing any protocol related procedures
• Adult healthy volunteers ≥ 18 to ≤ 60 years of age, male or female
• Female participants must fulfil one (1) of the following criteria:
• i) Post-menopausal; defined as either amenorrhea ≥ 12 months and confirmed with follicle stimulating hormone test ii) Females of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from at least 30 days before the study and for the duration of the study until 45 days post-intraperitoneal treatment. Adequate contraception includes:
• hormonal implant combined with a barrier method (male or female condom diaphragm with spermicidal foam/gel/film/cream/suppository or cervical cap with spermicide).
• intrauterine system (IUS) combined with a barrier method (male or female condom diaphragm with spermicidal foam/gel/film/cream/ suppository or cervical cap with spermicide).
• intrauterine device (IUD) combined with a barrier method (male or female condom diaphragm with spermicidal foam/gel/film/cream/ suppository or cervical cap with spermicide).
• hormonal patch combined with a barrier method (male or female condom diaphragm with spermicidal foam/gel/film/cream/ suppository or cervical cap with spermicide).
• hormonal contraceptive pills combined with a barrier method (male or female condom diaphragm with spermicidal foam/gel/film/cream/ suppository or cervical cap with spermicide).
• double-barrier methods (e.g., male condom with diaphragm and spermicide, male condom with cervical cap and spermicide).
• complete abstinence as a method of contraception is acceptable if in line with the subject's usual and preferred lifestyle.
• Male subjects who are non-vasectomized (or vasectomized less than six (6) months prior device application) and have female partners of childbearing potential must be willing to tell their female partner(s) that they are participating in a research study, and use an effective birth control method when having heterosexual intercourse, from treatment application until 45 days post-intraperitoneal treatment. Effective methods of contraception for use by males include:
• i) using a condom with a female partner of child-bearing potential who is using oral contraceptives, hormonal patch, implant or injection, intrauterine device, or diaphragm with spermicidal foam/gel/film/ cream/suppository.
• ii) complete abstinence as a method of contraception is acceptable if in line with the subject's usual and preferred lifestyle.
• In good general health as evaluated by the Principal Investigator

You may not qualify if:

• Are unable to give their own written informed consent
• Current pregnancy including ectopic pregnancy within last 6 months (including any previous ectopic pregnancy treated surgically) (female participants only)
• Positive pregnancy test (female participants only)
• Are breastfeeding (female participants only)
• Are within 3 months post-partum (female participants only)
• Are anticipated to attempt pregnancy within 45 days after intraperitoneal application
• Participant has donated blood in the following volumes:
• i) Between 50 mL and 499 mL within 30 days prior to the screening visit ii) 500 mL or more within 60 days prior to the screening visit
• Participant has a BMI of ≤ 18.5 or ≥ 30, and in the opinion of the Investigator does not have - Has undergone previous abdominopelvic surgery including laparoscopy, laparotomy, caesarean section, or other access that could have resulted in development of adhesions
• Has had symptoms, history, treatment or prior diagnosis of any inflammatory condition affecting the abdominopelvic cavity, including; endometriosis, pelvic inflammatory disease, chlamydia, polycystic ovaries, inflammatory bowel disease (including Crohn's disease, Ulcerative Colitis and Microscopic colitis), diverticulitis, irritable bowel syndrome, intestinal obstructive disease or other condition likely to result in abdominopelvic inflammation or sensitivity, or development of adhesions
• Have diabetes
• Have clinically significant abnormal blood results as reviewed by Principal Investigator
• Have creatinine clearance \<30 mL/min as per Cockcroft-Gault equation
• Concurrent use or anticipated use of systemic corticosteroids, antineoplastic agents within 2 months of intraperitoneal application
• Participant has received immunosuppressant therapy within last 30 days

Sponsors & Collaborators

• ARC Medical Inc.: lead

Study Sites (1)

Clinical trial site

Toronto, Canada

Location

Study Officials

• Chris Springate, PhD

  ARC Medical Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 26, 2019
• Study Start: June 18, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)