RECRUITING

Surgical Evaluation for Upper Extremity Lymphedema (BioBridge)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To investigate whether the addition of Fibralign's BioBridge® Collagen Matrix (BioBridge) devices 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 Nanofibrillar Collagen Scaffold (BioBridge®) as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema

Quick Facts

Study Start:2023-11-01

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05695924

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Ages 18 to 75 years (inclusive) * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 * Life expectancy \> 2 years * Acquired (secondary) upper limb lymphedema secondary to breast cancer treatment * The participant must be eligible for surgical intervention * Swelling of 1 limb that is not completely reversed by elevation or compression * Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system * Participants must have no evidence of disease (NED), have completed breast cancer therapy 3 years prior to enrollment; use of endocrine therapy is allowed. * Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen * Willingness to comply with recommended regimen of self care, with consistent use of compression garments from screening through the entire study duration (through the safety follow up visit), excluding the first 3 weeks postoperatively where patients are required to not wear compression. Self bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens are expected to remain consistent from screening though the entire study duration. * Consistent use of an appropriately sized compression garment for daytime use. * Limb volume (LV) in the affected limb and unaffected limb must be at least 10% of each other. * Evidence of abnormal bioimpedance ratio, if feasible, based upon unilateral disease: L Dex \> 10 units. * Willingness and ability to comply with all study procedures, including measurement of skin biopsy, and preoperative and postoperative imaging studies. * Willingness and ability to understand, and to sign a written informed consent form document	* Edema arising from increased capillary filtration will be excluded (venous incompetence). * 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 (≤ 12 weeks) of CDPT for lymphedema * Other medical condition that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure * Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (eg, pain, swelling, decreased range of motion) * History of clotting disorder (hypercoagulable state) * Chronic (persistent) infection in the affected limb * Infection of the lymphedema limb within 1 month prior to screening * Currently receiving chemotherapy or radiation therapy * Current evidence, or a history of malignancy within the past 3 years (except for non melanoma skin cancer or cervical cancer in situ treated with curative intent). If the participant has undergone cancer treatment, this must have been completed \> 3 years prior to enrollment. * 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 * Body Mass Index (BMI) \>35 * Known sensitivity to porcine products * Anaphylaxis to iodine * Pregnancy or nursing * Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening * Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study.

Inclusion Criteria

Exclusion Criteria

* Ages 18 to 75 years (inclusive)
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
* Life expectancy \> 2 years
* Acquired (secondary) upper limb lymphedema secondary to breast cancer treatment
* The participant must be eligible for surgical intervention
* Swelling of 1 limb that is not completely reversed by elevation or compression
* Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
* Participants must have no evidence of disease (NED), have completed breast cancer therapy 3 years prior to enrollment; use of endocrine therapy is allowed.
* Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen
* Willingness to comply with recommended regimen of self care, with consistent use of compression garments from screening through the entire study duration (through the safety follow up visit), excluding the first 3 weeks postoperatively where patients are required to not wear compression. Self bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens are expected to remain consistent from screening though the entire study duration.
* Consistent use of an appropriately sized compression garment for daytime use.
* Limb volume (LV) in the affected limb and unaffected limb must be at least 10% of each other.
* Evidence of abnormal bioimpedance ratio, if feasible, based upon unilateral disease: L Dex \> 10 units.
* Willingness and ability to comply with all study procedures, including measurement of skin biopsy, and preoperative and postoperative imaging studies.
* Willingness and ability to understand, and to sign a written informed consent form document

* Edema arising from increased capillary filtration will be excluded (venous incompetence).
* 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 (≤ 12 weeks) of CDPT for lymphedema
* Other medical condition that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure
* Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (eg, pain, swelling, decreased range of motion)
* History of clotting disorder (hypercoagulable state)
* Chronic (persistent) infection in the affected limb
* Infection of the lymphedema limb within 1 month prior to screening
* Currently receiving chemotherapy or radiation therapy
* Current evidence, or a history of malignancy within the past 3 years (except for non melanoma skin cancer or cervical cancer in situ treated with curative intent). If the participant has undergone cancer treatment, this must have been completed \> 3 years prior to enrollment.
* 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
* Body Mass Index (BMI) \>35
* Known sensitivity to porcine products
* Anaphylaxis to iodine
* Pregnancy or nursing
* Substance abuse (such as alcohol or drug abuse) within 6 months prior to 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

Study Contact

Shannon Meyer

CONTACT

650-721-1807

smeyer27@stanford.edu

Principal Investigator

Dung H Nguyen, MD, PharmD

STUDY_DIRECTOR

Stanford University

Study Locations (Sites)

Stanford University

Stanford, California, 94305

United States

Collaborators and Investigators

Sponsor: Fibralign Corporation

Dung H Nguyen, MD, PharmD, STUDY_DIRECTOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-01

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2023-11-01

Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

Lymphedema
Edema

Additional Relevant MeSH Terms

Lymphedema
Edema