Trial Outcomes & Findings for Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema (NCT NCT02734979)

Last Updated: 2022-10-27

Results Overview

Lymphoscintigraphy, a measure of limb volume indicative of adequate limb drainage, was conducted on the arm receiving BioBridge implantation (affected arm) and the contralateral (unaffected) arm, before surgery (baseline) and 1 year following surgical implantation of the Biobridge device. The outcome is reported as the median difference in the pre-implantation baseline value and the value 1 year after surgery for each arm.

Recruitment status

COMPLETED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

1 year

Results posted on

2022-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	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. Biobridge and lymph node transfer: Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biobridge and Lymph Node Transfer n=1 Participants 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. Biobridge and lymph node transfer: Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The units analyses are the affected arm (received BioBridge implant) and the unaffected contralateral arm.

Outcome measures

Outcome measures
Measure	Biobridge and Lymph Node Transfer n=1 Participants 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. Biobridge and lymph node transfer: Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery	Caliper Skin-fold Thickness - Forearm Caliper skin-fold thickness as measured at the forearm, of the arm receiving the BioBridge implant.	Caliper Skin-fold Thickness - Hand Caliper skin-fold thickness as measured on the back of the hand, of the arm receiving the BioBridge implant.	LYMQOL Survey - Symptoms LYMQOL survey for lymphedema symptoms in the arm receiving the BioBridge implant. Survey is a 4-point scale.	LYMQOL Survey - Mood LYMQOL survey for mood after receiving the BioBridge implant. Survey is a 4-point scale.
Change in Limb Volume BioBridge implant arm	-15 mL	—	—	—	—
Change in Limb Volume Unaffected contralateral arm	-202 mL	—	—	—	—

SECONDARY outcome

Timeframe: 1 year

Lymphoscintigraphy, a measure of limb volume for which changes are indicative of adequate limb drainage, was conducted on the arm receiving the BioBridge implantation (baseline) and 1 year following the Biobridge implantation. The outcome is reported as the median difference in measured volume for affected arm from baseline to 1 year.

Outcome measures

Outcome measures
Measure	Biobridge and Lymph Node Transfer n=1 Participants 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. Biobridge and lymph node transfer: Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery	Caliper Skin-fold Thickness - Forearm Caliper skin-fold thickness as measured at the forearm, of the arm receiving the BioBridge implant.	Caliper Skin-fold Thickness - Hand Caliper skin-fold thickness as measured on the back of the hand, of the arm receiving the BioBridge implant.	LYMQOL Survey - Symptoms LYMQOL survey for lymphedema symptoms in the arm receiving the BioBridge implant. Survey is a 4-point scale.	LYMQOL Survey - Mood LYMQOL survey for mood after receiving the BioBridge implant. Survey is a 4-point scale.
Serial Lymphoscintigraphy (LSG) Baseline	2295 mL	—	—	—	—
Serial Lymphoscintigraphy (LSG) 1 year	2280 mL	—	—	—	—

SECONDARY outcome

Timeframe: 1 year

Bioimpedance spectroscopy (BIS) is a non-invasive technique to measure the volume of fluid in various parts of the body, and can be used to assess the extent of lymphedema. BIS involves passing an extremely low-strength electrical current through the area and measuring how the flow of the current is slowed by the fluid in the body, and is reported as Ri in ohms, meaning the resistance of the intracellular fluid. BIS was conducted on the arm with the BioBridge implant, at baseline and 1 year after surgery. The outcome is reported as the median difference between baseline and 1 year after surgery in the arm receiving the BioBridge implant.

Outcome measures

Outcome measures
Measure	Biobridge and Lymph Node Transfer n=1 Participants 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. Biobridge and lymph node transfer: Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery	Caliper Skin-fold Thickness - Forearm Caliper skin-fold thickness as measured at the forearm, of the arm receiving the BioBridge implant.	Caliper Skin-fold Thickness - Hand Caliper skin-fold thickness as measured on the back of the hand, of the arm receiving the BioBridge implant.	LYMQOL Survey - Symptoms LYMQOL survey for lymphedema symptoms in the arm receiving the BioBridge implant. Survey is a 4-point scale.	LYMQOL Survey - Mood LYMQOL survey for mood after receiving the BioBridge implant. Survey is a 4-point scale.
Bioimpedance Spectroscopy Baseline	951.8 ohms	—	—	—	—
Bioimpedance Spectroscopy 1 year	977.3 ohms	—	—	—	—

SECONDARY outcome

Timeframe: 1 year

Skin fold thickness as measured by calipers was used as a measure of fluid retention. Skin fold thickness was measured at the upper arm, forearm, and back of the hand, at baseline and at 1 year following surgical implantation of the Biobridge device. An increase in skin thickness means increased fluid retention. The outcome is reported as the median difference of skin fold thickness in millimeters (mm) for each location on the arm receiving the BioBridge implant, from baseline to 1 year.

Outcome measures

Outcome measures
Measure	Biobridge and Lymph Node Transfer n=1 Skin-fold location 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. Biobridge and lymph node transfer: Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery	Caliper Skin-fold Thickness - Forearm n=1 Skin-fold location Caliper skin-fold thickness as measured at the forearm, of the arm receiving the BioBridge implant.	Caliper Skin-fold Thickness - Hand n=1 Skin-fold location Caliper skin-fold thickness as measured on the back of the hand, of the arm receiving the BioBridge implant.	LYMQOL Survey - Symptoms LYMQOL survey for lymphedema symptoms in the arm receiving the BioBridge implant. Survey is a 4-point scale.	LYMQOL Survey - Mood LYMQOL survey for mood after receiving the BioBridge implant. Survey is a 4-point scale.
Caliper Skin-fold Thickness Baseline	2.5 millimeters (mm)	3.5 millimeters (mm)	2.5 millimeters (mm)	—	—
Caliper Skin-fold Thickness 1 Year	3.25 millimeters (mm)	3.25 millimeters (mm)	2.25 millimeters (mm)	—	—

SECONDARY outcome

Timeframe: 1 year

Population: The per-protocol analysis was specified to be a blinded analysis, but with only a single set of specimens the analysis could not be conducted as defined.

Serial changes in histopathology will be determined via a blinded assessment of serial cutaneous punch biopsies specimens.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Quality-of-life was assessed using the LYMQOL survey, a 5-question survey for improved function, appearance, symptoms, mood, and overall QOL. Overall QoL was reported on a 10-point scale with 10 being best, and the other assessments were for disease impact on a 4-point response scale consisting of 1 (none), 2 (a little), 3 (quite a bit), 4 (a lot), with lower values representing minimal disease (lymphedema) impact on the parameter and higher values representing a greater negative effect on the parameter. The outcome is reported as the median.

Outcome measures

Outcome measures
Measure	Biobridge and Lymph Node Transfer n=1 Participants 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. Biobridge and lymph node transfer: Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery	Caliper Skin-fold Thickness - Forearm n=1 Participants Caliper skin-fold thickness as measured at the forearm, of the arm receiving the BioBridge implant.	Caliper Skin-fold Thickness - Hand n=1 Participants Caliper skin-fold thickness as measured on the back of the hand, of the arm receiving the BioBridge implant.	LYMQOL Survey - Symptoms n=1 Participants LYMQOL survey for lymphedema symptoms in the arm receiving the BioBridge implant. Survey is a 4-point scale.	LYMQOL Survey - Mood n=1 Participants LYMQOL survey for mood after receiving the BioBridge implant. Survey is a 4-point scale.
Quality of Life for Limb Lymphoedema (LYMQOL) Baseline	7 units on a scale	2.2 units on a scale	3.4 units on a scale	2.6 units on a scale	1.4 units on a scale
Quality of Life for Limb Lymphoedema (LYMQOL) 1 year	9 units on a scale	1.2 units on a scale	1.6 units on a scale	1.5 units on a scale	1.3 units on a scale

Adverse Events

Biobridge and Lymph Node Transfer

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Biobridge and Lymph Node Transfer n=1 participants at risk 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. Biobridge and lymph node transfer: Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery
Cardiac disorders Edema	100.0% 1/1 • Number of events 2 • 2 years 8 months

Additional Information

Dr. Stanley G Rockson, Allan and Tina Neill Professor of Lymphatic Research and Medicine

Stanford University

Phone: 650-725-7571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place