NCT01218269

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 11, 2010

Completed
Last Updated

March 1, 2011

Status Verified

September 1, 2010

Enrollment Period

1 year

First QC Date

October 7, 2010

Last Update Submit

February 28, 2011

Conditions

Microvascular Anastomoses

Keywords

anastomoses

Outcome Measures

Primary Outcomes (1)

  • Flap failure rate compared to published rate for conventional suture anastomoses

    will be measured 3 months postoperative (+/- 2 weeks)

Secondary Outcomes (1)

  • Rapid, reproducible, sutureless microvascular arterial anastomoses in free flaps without compromising patient outcomes.

    data collected at 3 months postoperative (+/- 2 weeks)

Study Arms (1)

no arms

OTHER

all patients will receive the treatment - there is only one arms

Device: nitinol u-clip

Interventions

nitinol u-clipDEVICE

The U-clip is comprised of nitinol, an alloy of nickel and titanium.

Also known as: Coalescent Surgical U-CLIPTbl
no arms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scott and White Hospital and Clinic

Temple, Texas, 76508, United States

Location

Study Officials

  • Raman C Mahabir, MD

    Scott & White

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2010

First Posted

October 11, 2010

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

March 1, 2011

Record last verified: 2010-09

Locations

US(1)