MedTrace Logo

Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures

NCT06304649 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-12

No results posted yet for this study

Summary

The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients.

A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product.

Conditions

  • Fractures, Closed
  • Fractures Bone
  • Fracture
  • Fractures
  • Radius; Fracture, Lower or Distal End
  • Ulna Fractures
  • Radius Distal Fracture

Interventions

DEVICE

Cast or brace alternative

Waterproof alternative to a cast or brace for broken bones

Sponsors & Collaborators

  • Cast21

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2024-10-31
Completion
2024-12-31

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 NCT06304649 on ClinicalTrials.gov