Last updated: July 8, 2021
Sponsor: SurgiQuest, Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Lymphedema
Treatment
N/AClinical Study ID
NCT04165525
DD01112019
Ages 18-80 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18 to 80 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for a unilateral or bilateral mastectomy and reconstruction. Allsubjects enrolled and consented will undergo mastectomy with a breast reconstructionprocedure, if it is in the subject's best interest.
Exclusion
Exclusion Criteria:
- Advanced refusal of blood transfusion, if necessary;
- Active systemic or cutaneous infection or inflammation;
- Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
- Uncontrolled diabetes mellitus
- Known, significant history of bleeding diathesis, or coagulopathy, or Von Willebrand'sdisease or current platelet count < 100,000 cells/mm3, or baseline INR ≥1.8, orfibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24hours);
- Severe co-existing morbidities having a life expectancy of less than 30 days;
- Currently involved in any other investigational clinical studies that could influenceoutcomes;
- Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
- Renal insufficiency (serum creatinine of > 2.5 mg/dl);
- Females who are pregnant, planning to become pregnant within 3 months of theprocedure, or lactating;
- Patients who have had previous partial mastectomies with scar tissue affecting thearea to be resected.
Study Design
Total Participants: 82
Study Start date:
May 26, 2021
Estimated Completion Date:
December 30, 2022
Study Description
Connect with a study center
Baylor St. Luke's Medical Center
Houston, Texas 77030
United StatesActive - Recruiting
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