Status:
COMPLETED
Minimally Invasive Groin Dissection for Melanoma
Lead Sponsor:
Mayo Clinic
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this this study is to determine if a structured educational training program is successful in teaching surgeons a new operative technique. It will then be determined if this new operati...
Detailed Description
This study is a multi-center, Phase 1 clinical trial to determine the safety and feasibility of minimally invasive inguinal lymph node dissection for patients with melanoma. Licensed surgeons who have...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Malignant melanoma present in an inguinal nodal basin requiring superficial inguinal lymph node dissection.
- Plan for superficial inguinal dissection alone or combined superficial inguinal and deep pelvic node dissection is acceptable.
- Clinical or radiographic evidence of superficial inguinal lymph node disease or a prior positive single lymph node biopsy of the superficial inguinal basin as an indication for superficial inguinal lymph node disease is acceptable.
- Patients must be Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and be healthy enough to undergo a general anesthetic (no epidural or spinal anesthetics).
- Female patients of child bearing age must have a negative pregnancy test, be surgically sterile or post-menopausal greater than 1 year.
- Patients must be able to return to surgical facility for 30 and/or 90 day (+/- 20 days) for follow-up appointment.
- Exclusion Criteria:
- Prior ipsilateral superficial inguinal lymph node dissection
- Invasion or ulceration of inguinal nodal disease into the overlying skin
- Prior radiation therapy to the same regional nodal basin.
Exclusion
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01500304
Start Date
June 1 2012
End Date
December 1 2015
Last Update
March 23 2018
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
3
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
4
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612