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Examining the Effectiveness of a Connective Tissue Matrix Implant in Reducing Post-operative Pain and Narcotic After Outpatient Arthroscopic Shoulder Surgery

NCT04633837 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-01-06

Study results available
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Summary

This document is a protocol for a human research study. This study is to be conducted according to United States standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures.

Extracellular matrix grafts have been used to help with postoperative inflammation.

Conditions

  • Arthroscopic Shoulder Surgery
  • Pain, Postoperative

Interventions

DEVICE

Extracellular Matrix Graft Injectable Implant

The extracellular matrix injectable implant will serve as the intervention in this study.

Sponsors & Collaborators

  • CTM Biomedical

    collaborator INDUSTRY

  • Brian Badman

    lead OTHER

Principal Investigators

  • brian l badman, MD · American Health Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-04
Primary Completion
2021-11-07
Completion
2021-11-07
FDA Device
Yes

Countries

  • United States

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 NCT04633837 on ClinicalTrials.gov