Microvascular AnastomosesPhase 4NCT01218269
U-clip Pilot Study in Plastic Surgery
A Phase 4 study testing nitinol u-clip in people with Microvascular Anastomoses, run by Scott and White Hospital & Clinic at 1 site in United States.
Trial summary
This study will assess the nitinol U-clip as an alternative to conventional microsurgical suture for arterial anastomoses in free tissue transfer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microvascular Anastomoses
- What is being tested?
- nitinol u-clip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 2010
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- less than 18 years of age
- allergy to nitinol or any of its components (nickel or titanium)
- pregnancy
- known coagulopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Scott and White Hospital and Clinic
Temple, Texas, 76508
About this study
Official title: A Prospective Evaluation of U-clips for Arterial Microvascular Anastomoses
This study will assess the nitinol U-clip as an alternative to conventional microsurgical suture for arterial anastomoses in free tissue transfer.
Read the 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.
- Conditions
- Microvascular Anastomoses
- Being tested
- nitinol u-clip
- Keywords
- anastomoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitinol u-clipDevice
Also called Coalescent Surgical U-CLIPTbl
The U-clip is comprised of nitinol, an alloy of nickel and titanium.
| Study group | Role | What they receive |
|---|---|---|
| no arms | Other | all patients will receive the treatment - there is only one arms Receives: Device: nitinol u-clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flap failure rate compared to published rate for conventional suture anastomoses
Measured: will be measured 3 months postoperative (+/- 2 weeks)
Secondary outcomes (1)
Rapid, reproducible, sutureless microvascular arterial anastomoses in free flaps without compromising patient outcomes.
Measured: data collected at 3 months postoperative (+/- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular AnastomosesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scott and White Hospital & Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Raman C Mahabir, MD, Principal investigator, Scott & White
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218269
- Sponsor's protocol ID
- SWHospital - 90415
- Status last verified
- Sep 2010
- First submitted
- 7 Oct 2010
- Last updated
- 1 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of U-clips for Arterial Microvascular Anastomoses
- ClinicalTrials.gov ID
- NCT01218269
- Acronym / sponsor ID
- SWHospital - 90415
- Conditions
- Microvascular Anastomoses
- Keywords
- anastomoses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Scott and White Hospital & ClinicUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 Oct 2010 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no arms | Other | Device: nitinol u-clipall patients will receive the treatment - there is only one arms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- less than 18 years of age
- allergy to nitinol or any of its components (nickel or titanium)
- pregnancy
- known coagulopathy
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 |
|---|---|---|
| nitinol u-clipAlso: Coalescent Surgical U-CLIPTblThe U-clip is comprised of nitinol, an alloy of nickel and titanium. | Device | no arms |
Primary outcome
Flap failure rate compared to published rate for conventional suture anastomoses
Time frame: will be measured 3 months postoperative (+/- 2 weeks)
1 secondary outcome
Rapid, reproducible, sutureless microvascular arterial anastomoses in free flaps without compromising patient outcomes.
Time frame: data collected at 3 months postoperative (+/- 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2011.
Related trials for Microvascular Anastomoses
RecruitingObservational study
Continuous Monitoring of Microvascular Anastomoses: An Observational Trial
Head and Neck Neoplasm
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.
Raman C Mahabir, MD principal investigator
Scott & White
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nitinol u-clip in people with Microvascular Anastomoses, run by Scott and White Hospital & Clinic 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 1 Mar 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Flap failure rate compared to published rate for conventional suture anastomoses (time frame: will be measured 3 months postoperative (+/- 2 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 Mar 2011.