Adaprev in Digital Flexor Tendon Repair | NCT01014494

Studies
Adaprev in Digital Flexor Tendon Repair

NCT01014494

Sponsor

Renovo

Status

Unknown status

Last Update Posted

Dec 9, 2010Estimated

Enrollment

44Estimated

Phase

Not Applicable

Conditions

Tendon Injuries

Interventions

Adaprev

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Nov 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Nov 16, 2009

First Submission Date that Met QC Criteria

Nov 16, 2009

First Posted Date

Nov 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2010

Last Update Posted Date

Dec 9, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active - Adaprev	Experimental	Adaprev (Class III medical device)	Device: Adaprev
Standard Care	No Intervention	No different treatment to normal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adaprev	Device	Class III Medical Device	Active - Adaprev	Product contains mannose-6-phosphate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary trial endpoint will be the assessment of safety and local tolerability for a period up to twenty six weeks after dosing.		26 weeks post surgery

Secondary Outcomes

Measure	Description	Time Frame
The secondary endpoint will be an evaluation of the performance of Adaprev™ as measured by the range of motion of the treated finger at twenty six weeks after tendon repair		26 weeks post surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Subjects aged 18 years and above with complete division of the Flexor Digitorum Profundus (FDP) tendon in Zone II.

Exclusion Criteria:

Subjects with additional complicated injuries
Subjects whose flexor tendon repair involves a finger with less than full tendon function prior to the injury requiring repair
Subjects who are undergoing surgical repair of the severed tendon(s) more than four days after the injury occurred.
Subjects with a history of clinical significant hypersensitivity to any of the devices, drugs or surgical dressings to be used in this trial.
Subjects with conditions which may delay healing.
Subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
Females who are pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Hutchison, MBBS PhD	Renovo Ltd	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mr P Gillespie	Recruiting	Addenbrooke's Hospital, Cambridge	Cambridge	CB2 0QQ	United Kingdom