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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 2016 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanley Rockson, Stanford University
ClinicalTrials.gov Identifier:
NCT02734979
First received: April 5, 2016
Last updated: April 19, 2016
Last verified: April 2016

April 5, 2016
April 19, 2016
April 2016
May 2019   (Final data collection date for primary outcome measure)
Limb volume reduction [ Time Frame: 1 year ]
Quantitative reduction in volume of the treated limb
Same as current
Complete list of historical versions of study NCT02734979 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Prospective Evaluation of the Biobridge Scaffold as an Adjunct to Lymph Node Transfer for Upper Extremity Lymphedema
Prospective Evaluation of the Biobridge Scaffold as an Adjunct to Vascularized Lymph Node Transfer for Upper Extremity Lymphedema
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphedema
  • Edema
Device: Biobridge and lymph node transfer
Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery
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.
Intervention: Device: Biobridge and lymph node transfer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
January 2020
May 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact: Leslie Roche, RN 659-725-7571 lesroche@stanford.edu
Contact: Nancy L Yang 650-723-1396 nlyang@stanford.edu
United States
 
 
NCT02734979
37161
No
Not Provided
Yes
The data will be published in peer review format and raw data will be available on request by individual investigators or institutions
Stanley Rockson, Stanford University
Stanford University
Not Provided
Principal Investigator: Stanley G Rockson, MD Stanford University
Stanford University
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP