Other Reconstructive SurgeryNCT00792792
Monitoring of Tissue Transfer Flaps by Modulated Imaging
An observational study of Other Reconstructive Surgery, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other Reconstructive Surgery
- What is being tested?
- Modulated Imaging
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Adult 18 years and older planned to undergo reconstructive surgery
Who cannot join
- All emergency reconstructive surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Medical Center
Orange, California, 92868
About this study
Official title: Non-contact, Intra-operative & Post-operative Device, Evaluation of Tissue Transfer Flaps After Reconstructive Surgery.
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.
Read the 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.
- Conditions
- Other Reconstructive Surgery
- Being tested
- Modulated Imaging
- Keywords
- tissue transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modulated ImagingDevice
Modulated Imaging Spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| Tissue transfer skin flap | Modulated Imaging Spectroscopy Receives: Device: Modulated Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfer Skin flap
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startJan 2007
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Why it stopped: Not a clinical trial study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Reconstructive SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Evans R Gregory, PhD, Principal investigator, Aesthetic & Plastic Surgery Institute, UCIMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792792
- Sponsor's protocol ID
- 20075891
- Status last verified
- Oct 2022
- First submitted
- 14 Nov 2008
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-contact, Intra-operative & Post-operative Device, Evaluation of Tissue Transfer Flaps After Reconstructive Surgery.
- ClinicalTrials.gov ID
- NCT00792792
- Acronym / sponsor ID
- 20075891
- Conditions
- Other Reconstructive Surgery
- Keywords
- tissue transfer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not a clinical trial study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Jan 2007
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 18 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tissue transfer skin flap | – | Device: Modulated ImagingModulated Imaging Spectroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- Adult 18 years and older planned to undergo reconstructive surgery
Key exclusion criteria (1 listed)
- All emergency reconstructive surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modulated ImagingModulated Imaging Spectroscopy | Device | Tissue transfer skin flap |
Primary outcome
Transfer Skin flap
Time frame: up to 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evans R Gregory, PhD principal investigator
Aesthetic & Plastic Surgery Institute, UCIMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Other Reconstructive Surgery, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transfer Skin flap (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.