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NCT00633503 · ClinicalTrials.gov registry record
Monitoring of Tissue Transfer Flaps by Modulated Imaging (MI) Spectroscopy
A clinical trial, sponsored by University of California, Irvine.
- Completed
- Registry status
- 26
- Enrollment target
NCT00633503 is a clinical trial that has completed, run by University of California, Irvine. The registered enrollment target is 26 participants.
The verdict
NCT00633503 has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- 26 participants
- Enrollment target
Study 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 \& veins at the recipient site. The process of reconstructive surgery using tissue transfer flaps allows for improved results in terms of functionality, aesthetic appearance, and psychological well-being in patients requiring reconstructive surgery after cancer resection or trauma. 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. The purpose of this pilot study is to determine if a novel, unique, portable, non-contact optical imaging device developed at the Beckman Laser Institute called Modulated Imaging (MI) can detect changes in a flap's optical properties, which can correlate with arterial or venous occlusion or with the development of fat necrosis or flap atrophy. The study would also evaluate if changes in the tissue transfer flap's optical properties, as detected by the device could be employed as a monitoring device in the post-operative period after reconstructive surgery. The MI device's detection of specific optical properties of a tissue flap could also potentially be used as a diagnostic tool to predict the likelihood of the development of fat necrosis or flap atrophy in a delayed fashion several months after reconstructive surgery. Prior animal and clinical studies using similar devices have demonstrated that changes in the total hemoglobin concentration and percentage of oxygenated hemoglobin in the tissue transfer flap can be used to differentiate between arterial and venous occlusion. These other similar devices have been shown to be able to detect venous occlusion prior to clinical manifestations of venous
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-01 |
| Est. Completion | 2020-01-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00633503
The ClinicalTrials.gov registry entry for NCT00633503 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00633503 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00633503 about?
NCT00633503 is a clinical study titled "Monitoring of Tissue Transfer Flaps by Modulated Imaging (MI) Spectroscopy". 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 \& veins at the recipient site. The process of reconstr...
What is the current status of trial NCT00633503?
This trial is currently completed. The enrollment target is 26 participants. The study started on 2011-01. Estimated completion is 2020-01-15.
Who is sponsoring clinical trial NCT00633503?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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