Monitoring of Tissue Transfer Flaps by Modulated Imaging | NCT00792792

Studies
Monitoring of Tissue Transfer Flaps by Modulated Imaging

NCT00792792

Sponsor

University of California, Irvine

Status

Withdrawn

Last Update Posted

Nov 1, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Other Reconstructive Surgery

Interventions

Modulated Imaging

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not a clinical trial study.

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jun 2018Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Nov 14, 2008

First Submission Date that Met QC Criteria

Nov 14, 2008

First Posted Date

Nov 18, 2008Estimated

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

Oct 28, 2022

Last Update Posted Date

Nov 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beckman Laser Institute and Medical Center, Gregory Evans, M.D., Chair, Department of Plastic Surgery, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Name	Class
Beckman Laser Institute University of California Irvine	OTHER

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

Tissue transfer flaps are a method of moving tissue from a donor location to a recipient location. In the case of a free tissue transfer flaps, the blood vessels to the transferred tissues are detached and then re-attached to different arteries and veins at the recipient site. The process of reconstructive surgery using tissue transfer flaps is not without complications. These complications may include acute arterial or venous occlusion, as well as the development of late complications such as fat necrosis and flap atrophy.

Detailed Description

The researchers developed a safe, non-contact, intra-operative and post-operative device called Modulated Imaging, can detect changes in a flap's optical properties and can correlate with arterial or venous occlusion or with the development of fat necrosis or flap atrophy.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tissue transfer skin flap		Modulated Imaging Spectroscopy	Device: Modulated Imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Modulated Imaging	Device	Modulated Imaging Spectroscopy	Tissue transfer skin flap

Measure	Description	Time Frame
Transfer Skin flap		up to 6 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult 18 years and older planned to undergo reconstructive surgery

Exclusion Criteria:

All emergency reconstructive surgery

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

Study population will be selected from Surgical Department as outpatients and in-patient bases that require reconstructive surgery using a pedicle or free tissue transfer flap.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Evans R Gregory, PhD	Aesthetic & Plastic Surgery Institute, UCIMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California Medical Center		Orange	California	92868	United States