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Adaprev in Digital Flexor Tendon Repair

NCT01014494 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2010-12-09

No results posted yet for this study

Summary

This study is being undertaken to verify the safety and performance of Adaprev™, a Class III medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function of severed digital tendons. Subjects are randomised to either Adaprev or standard care and attend visits for 26 weeks following surgery. This clinical investigation will recruit 44 subjects in the UK at up to 10 clinical trial sites.

Conditions

  • Tendon Injuries

Interventions

DEVICE

Adaprev

Class III Medical Device

Sponsors & Collaborators

  • Renovo

    lead INDUSTRY

Principal Investigators

  • John Hutchison, MBBS PhD · Renovo Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-11-30
Completion
2011-12-31

Countries

  • United Kingdom

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 NCT01014494 on ClinicalTrials.gov