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CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

Prospective Evaluation of the Biobridge Scaffold as an Adjunct to Lymph Node Transfer for Upper Extremity Lymphedema

Trial ID or NCT#

NCT02734979

Status

NOT RECRUITING

Purpose

To investigate whether addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm.

Official Title

Prospective Evaluation of the Biobridge Scaffold as an Adjunct to Vascularized Lymph Node Transfer for Upper Extremity Lymphedema

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

Inclusion Criteria:

The diagnosis of obstructive lymphedema typically relies upon the clinical presentation and physical findings. All of the subjects will be required to present a compatible history of acquired lymphedema, along with the following criteria: sustained, unilateral, conservatively-managed edema of the upper limb, with an increase of at least 20% in the measured volume of the affected extremity when compared with the contralateral, normal limb. In addition, the subject must have evidence of an abnormal bioimpedance ratio (L-Dex > 10 units). The subject must submit evidence of previous, completed complex decongestive physiotherapy and the ongoing use of an appropriately sized compression garment for daytime use. Ancillary use of nocturnal garments and/or pneumatic compression devices is acceptable, but not necessary. The subject must be eligible for surgical intervention.

- Swelling of 1 arm that is not completely reversed by arm elevation or compression
- Stage II or greater lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
- Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 8 weeks prior to screening, including use of compression garments for at least 8 weeks without change in regimen
- Willingness to maintain a stable regimen of self-care, including use of compression garments from screening through the entire study duration (through the safety follow-up visit). Self-bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens must remain consistent from screening though the entire study duration.
- Two consecutive measurements of limb volume (LV) in the affected arm taken at least 1 day apart during the screening period must be within 10% of each other. A maximum of 3 measurements can be taken.
- Willing and able to provide written informed consent
- Willing and able to comply with all study procedures, including measurement of skin thickness using skin calipers

Exclusion Criteria:

- inability to safely undergo general anesthesia and/or perioperative care related to vascularized lymph node transfer
- Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within

1 month before screening or 5 times the drug's half-life, whichever is longer

- Recent initiation of (≤8 weeks), or intention to initiate, CDPT or maintenance physiotherapy for lymphedema at any time during the duration of the study
- Other medical condition that could lead to acute arm edema, such as (but not limited) to acute venous thrombosis
- Other medical condition that could result in symptoms overlapping those of lymphedema in the affected arm (e.g.,pain, swelling, decreased range of motion)
- History of clotting disorder (hypercoagulable state)
- Chronic (persistent) infection in the affected arm
- Any other infection (unrelated to lymphedema) within 1 month prior to screening
- Current evidence of malignancy
- Currently receiving chemotherapy or radiation therapy
- Life expectancy < 2 years for any reason
- Pregnancy or nursing
- Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening
- Significant or chronic renal insufficiency (defined as serum creatinine >2.5 mg/dL or an estimated glomerular filtration rate [eGFR] <30 mL/min at screening) or requires dialytic support
- Hepatic dysfunction, defined as alanine transaminase (ALT) or aspartate transaminase (AST) levels >3 × upper limit of the normal range (ULN) and/or bilirubin level >2 × ULN at screening
- Absolute neutrophil count <1500 mm3 at screening
- Hemoglobin concentration <9 g/dL at screening
- Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study

View All Criteria

Investigator(s)

Stanley G. Rockson, MD

Cardiologist

Allan and Tina Neill Professor of Lymphatic Research and Medicine

Dung Nguyen, MD, Pharm.D

Plastic and reconstructive surgeon, Breast reconstructive surgeon, Breast surgeon, Cosmetic plastic surgeon, Plastic surgeon

Clinical Associate Professor, Surgery - Plastic & Reconstructive Surgery

CONTACT

Eric Henderson
(650) 723-1396

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View on ClinicalTrials.gov

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