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NCT04679701

Using Direct Molding Socket Technology for Trans-tibial Prosthesis in Developing Regions

Completed Last updated 22 December 2020
What this trial tests

trial testing Amparo Confidence Socket in Transtibial Amputees in 27 participants. Completed in 30 November 2020.

Timeline
8 July 2019
Primary endpoint
12 March 2020
30 November 2020

Quick facts

Lead sponsorAmparo GmbH
StatusCompleted
Study typeOBSERVATIONAL
Enrollment27
Start date8 July 2019
Primary completion12 March 2020
Estimated completion30 November 2020
Sites2 locations across Kenya

Drugs / interventions tested

Conditions studied

Sponsor

Amparo GmbH

Who can join

18 and older, any sex, with Transtibial Amputees. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study aims to understand how well CPOs and amputees can adapt to using the Amparo socket technology. CPOs at the APDK and The Cure will be trained to use the Amparo socket technology then use it with their consenting patients for a span of 7 months. Survey information will be collected along the way to assess how well the product is adapted by CPOs and patients.

Publications & conference data

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

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04679701.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing