U-clip Pilot Study in Plastic Surgery | NCT01218269

Studies
U-clip Pilot Study in Plastic Surgery

NCT01218269

Sponsor

Scott and White Hospital & Clinic

Status

Completed

Last Update Posted

Mar 1, 2011Estimated

Enrollment

25Actual

Phase

Phase 4

Conditions

Microvascular Anastomoses

Interventions

nitinol u-clip

Countries

United States

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

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Oct 7, 2010

First Submission Date that Met QC Criteria

Oct 8, 2010

First Posted Date

Oct 11, 2010Estimated

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

Feb 28, 2011

Last Update Posted Date

Mar 1, 2011Estimated

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 will assess the nitinol U-clip as an alternative to conventional microsurgical suture for arterial anastomoses in free tissue transfer.

Detailed Description

Within Scott & White, a total of 25 free flaps will be performed using U-clips for microvascular anastomoses in lieu of traditional suturing techniques. Each of these free flaps may be in individual patients or two anastomoses may be included in one patient. Historical controls will be used for comparison of complication rates of U-clip versus sutured anastomoses. Postoperatively, the study participants will be evaluated at 2 weeks (+/- 1 week) and at 3 months (+/- 1 month) follow up.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
no arms	Other	all patients will receive the treatment - there is only one arms	Device: nitinol u-clip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nitinol u-clip	Device	The U-clip is comprised of nitinol, an alloy of nickel and titanium.	no arms

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Flap failure rate compared to published rate for conventional suture anastomoses		will be measured 3 months postoperative (+/- 2 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Rapid, reproducible, sutureless microvascular arterial anastomoses in free flaps without compromising patient outcomes.		data collected at 3 months postoperative (+/- 2 weeks)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

either gender
any ethnicity
patient requiring free tissue transfer for complex wound coverage or reconstruction
patient having arterial anastomotic diameter of at least 2 mm
patient capable of giving informed consent

Exclusion Criteria:

less than 18 years of age
allergy to nitinol or any of its components (nickel or titanium)
pregnancy
known coagulopathy

Accepts Healthy Volunteers

Yes

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
Raman C Mahabir, MD	Scott & White	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scott and White Hospital and Clinic		Temple	Texas	76508	United States