|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02274493 |
|
Date of registration:
|
22/10/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Robotic Harvest of the Latissimus Dorsi (LD) Muscles
|
|
Scientific title:
|
Pilot Study of Robotic-Assisted Harvest of the Latissimus Dorsi Muscles |
|
Date of first enrolment:
|
July 8, 2015 |
|
Target sample size:
|
15 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02274493 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Jesse C. Selber, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
M.D. Anderson Cancer Center |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. The subject must be equal to or greater than 18 years of age.
2. The subject must be willing and able to provide informed consent.
3. The subject is willing and able to comply with the study protocol.
4. The subject is undergoing one of the following reconstructive procedures that requires
latissimus dorsi muscle harvest: a. Post-mastectomy breast reconstruction procedure
(either nipple or skin sparing) in which a female subject needs additional muscle
coverage over an implant, but does not need additional skin (i.e., patient is a
candidate for a pedicled latissimus dorsi muscle flap procedure); b. Scalp
reconstruction procedure in which the subject needs a free latissimus dorsi muscle
flap for wound coverage; c. Upper extremity reconstruction procedure in which the
subject needs a free latissimus dorsi muscle flap for wound coverage; or, d. Lower
extremity reconstruction procedure in which the subject needs a free latissimus dorsi
muscle flap for wound coverage.
5. The subject agrees to follow-up examinations out to 6 months post-treatment.
Exclusion Criteria:
1. The subject has a BMI > 35.
2. The subject has a history of significant bleeding disorders.
3. The subject is diabetic.
4. The subject is known or suspected to be pregnant or lactating.
5. The subject has a history of peripheral vascular disease.
6. The subject is a current smoker (has smoked within 4 weeks prior to surgery).
7. The subject has had prior back or axillary surgeries which could compromise the blood
supply of the flap.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Other Reconstructive Surgery
|
|
Cancer
|
|
Complications
|
|
Failure of Muscle Graft
|
|
Surgical Procedure, Unspecified
|
|
Intervention(s)
|
|
Procedure: Reconstructive surgery
|
|
Behavioral: Questionnaires
|
|
Procedure: LD muscle flap harvest procedure
|
|
Device: da Vinci® Robotic Surgical System
|
|
Primary Outcome(s)
|
|
Number of Participants With LD Muscle Flap Viability Following Robotic-Assisted Harvest Procedure
[Time Frame: Participants were followed for up to a total of 6 months post-operatively]
|
|
Number of Participants Assessed for Donor Site Complications and Muscle Flap Viability
[Time Frame: Participants were followed for up to a total of 6 months post-operatively]
|
|
Secondary Outcome(s)
|
|
Evaluation of Donor Site Complications Through 6 Months Post-procedure
[Time Frame: Participants were followed for up to a total of 6 months post-operatively]
|
|
LD Muscle Flap Failure Through 6 Months Post-procedure
[Time Frame: Participants were followed for up to a total of 6 months post-operatively]
|
|
Secondary ID(s)
|
|
2013-0232
|
|
NCI-2015-00616
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|