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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Stanley Rockson, Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanley Rockson, Stanford University
ClinicalTrials.gov Identifier:
NCT02734979
First received: April 5, 2016
Last updated: April 24, 2017
Last verified: April 2017
  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.

Condition Intervention
Lymphedema Edema Device: Biobridge and lymph node transfer

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Prospective Evaluation of the Biobridge Scaffold as an Adjunct to Vascularized Lymph Node Transfer for Upper Extremity Lymphedema

Resource links provided by NLM:


Further study details as provided by Stanley Rockson, Stanford University:

Primary Outcome Measures:
  • Limb volume reduction [ Time Frame: 1 year ]
    Quantitative reduction in volume of the treated limb


Secondary Outcome Measures:
  • Serial lymphoscintigraphy [ Time Frame: 1 year ]
    Quantitative changes in axillary lymph node function and transit times on serial lymphoscintigraphy will be serially assessed

  • Bioimpedance spectroscopy [ Time Frame: 1 year ]
    Serial changes in bioimpedance spectroscopy will be quantitated

  • Caliper skin fold thickness [ Time Frame: 1 year ]
    Serial changes in caliper skin fold thickness will be quantitated

  • Cutaneous punch biopsy of skin [ Time Frame: 1 year ]
    Serial changes in histopathology will be assessed with serial cutaneous punch biopsy

  • Quality of life [ Time Frame: 1 year ]
    Quality of life parameters will be quantitated serially with a validated instrument


Estimated Enrollment: 60
Study Start Date: April 2016
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biobridge and lymph node transfer
The investigators will 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. The investigators will perform lymph scans (lymphoscintigrams) before surgery and one year following surgery to determine the success of the surgery. In addition, the volume of the operated arm will be monitored by repeated measurement with a tape measure. The investigators will also track bioimpedance, a painless technique to detect fluid in the tissues. The investigators will obtain small skin biopsies and blood samples to detect the biological changes that may occur as a result of successful surgery.
Device: Biobridge and lymph node transfer
Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery

Detailed Description:
The investigators will perform lymph scans (lymphoscintigrams) before surgery and one year following surgery to determine the success of the surgery. In addition, the volume of the operated arm will be monitored by repeated measurement with a tape measure. The investigators will also track bioimpedance, a painless technique to detect fluid in the tissues. The investigators will obtain small skin biopsies and blood samples to detect the biological changes that may occur as a result of successful surgery.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02734979

Contacts
Contact: Leslie Roche, RN 659-725-7571 lesroche@stanford.edu
Contact: Nancy L Yang 650-723-1396 nlyang@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Eric Henderson    650-723-1396    ehenders@stanford.edu   
Contact: Leslie Roche, RN    650-725-7571    lesroche@stanford.edu   
Principal Investigator: Stanley G Rockson, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Stanley G Rockson, MD Stanford University
  More Information

Responsible Party: Stanley Rockson, Allan and Tina Neill Professor of Lymphatic Research and Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02734979     History of Changes
Other Study ID Numbers: 37161
Study First Received: April 5, 2016
Last Updated: April 24, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: The data will be published in peer review format and raw data will be available on request by individual investigators or institutions

Keywords provided by Stanley Rockson, Stanford University:
lymphedema
edema

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on June 28, 2017