NCT03492476

Circaid® Compression Sleeve Versus Short-stretching Bandage in Upper Limb Lymphatic Edema

Completed NA Last updated 2 March 2023

What this trial tests

NA trial testing Circaid in Lymphedema of Upper Arm in 142 participants. Completed in 2 March 2022.

Timeline

8 September 2017

Primary endpoint
2 March 2022

2 March 2022

Quick facts

Lead sponsor	CEN Biotech
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	142
Start date	8 September 2017
Primary completion	2 March 2022
Estimated completion	2 March 2022
Sites	4 locations across France

Drugs / interventions tested

• Circaid
• Short-stretching Bandage (Reference treatment)

Conditions studied

• Lymphedema of Upper Arm — all drugs for Lymphedema of Upper Arm →

Sponsor

CEN Biotech — full company profile →

Who can join

18 and older, female only, with Lymphedema of Upper Arm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

One of the difficulties encountered in the treatment of lymphedema, both in the active reduction phase and in the maintenance phase, is the appliance of the short-length compression bandages which requires good technicality and experience to exert the pressure required to remove liquids from tissue spaces and reduce the volume of the arm or prevent it from increasing again.

The study aims to compare the current protocol of care considered optimal for the reduction of lymphedema and the maintenance of this reduction with the protocol of care which would integrate the device circaid® in substitution to the laying of bands with short extension as it is now in other countries.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.