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Efficacy of CTM for Tennis ELbow

NCT06171555 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-03-27

No results posted yet for this study

Summary

In this study, the objective is to evaluate the effectiveness of a single application of human Connective Tissue Allograft (CTA) as a treatment of LET. CTM Biomedical markets and distributes decellularized particulate human placental connective-tissue matrix products, intended solely for homologous use to supplement or replace damaged or inadequate connective-tissue. These are structural tissue allografts processed according to the criteria contained in 21CFR 1271.10(a) for regulation solely under section 361 of the Public Health Service Act. Drug/Device Handling: If the research involves drugs or device, describe your plans to store, handle, and administer those drugs or devices so that they will be used only on subjects and be used only by authorized investigators.

Conditions

  • Tennis Elbow
  • Lateral Epicondylitis \(Tennis Elbow\)
  • Lateral Elbow Tendinopathy

Interventions

DEVICE

CTM

decellularized particulate human placental connective-tissue matrix products, intended solely for homologous use to supplement or replace damaged or inadequate connective-tissue. These are structural tissue allografts processed according to the criteria contained in 21CFR 1271.10(a) for regulation solely under section 361 of the Public Health Service Act.

DRUG

Celestone

standard of care

Sponsors & Collaborators

  • CTM Biomedical

    collaborator INDUSTRY

  • Indiana Hand to Shoulder Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-26
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06171555 on ClinicalTrials.gov