Trial Outcomes & Findings for Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema (NCT NCT02946021)
NCT ID: NCT02946021
Last Updated: 2019-04-09
Results Overview
Demonstrate the ability of the Flexitouch system to move lymph/enhance lymphatic uptake (indicated by increased functionality of vessels and/or changes in area of dermal backflow) as measured by Indocyanine Green (ICG) lymphography.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Single Treatment, 2 Weeks of Treatment
Results posted on
2019-04-09
Participant Flow
Participant milestones
| Measure |
Pneumatic Compression-1 Session Per Day
Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).
Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.
|
Pneumatic Compression-2 Sessions Per Day
Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).
Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema
Baseline characteristics by cohort
| Measure |
Pneumatic Compression-1 Session Per Day
n=6 Participants
Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).
Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.
|
Pneumatic Compression-2 Sessions Per Day
n=5 Participants
Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).
Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Single Treatment, 2 Weeks of TreatmentPopulation: The analysis population included all enrolled subjects who completed the study and properly used the device. One subject reported wearing the head garment upside down during the two week treatment period, therefore the subject was excluded from the analysis population for a cohort of 10 analyzable data sets.
Demonstrate the ability of the Flexitouch system to move lymph/enhance lymphatic uptake (indicated by increased functionality of vessels and/or changes in area of dermal backflow) as measured by Indocyanine Green (ICG) lymphography.
Outcome measures
| Measure |
Pneumatic Compression-1 Session Per Day
n=5 Participants
Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).
Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.
|
Pneumatic Compression-2 Sessions Per Day
n=5 Participants
Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).
Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.
|
|---|---|---|
|
Lymph Movement Measured by ICG Lymphography.
Lymph Movement after 2 Weeks of Treatment · No Enhanced Lymphatic Uptake
|
0 Participants
|
1 Participants
|
|
Lymph Movement Measured by ICG Lymphography.
Lymph Movement after Single Treatment · Enhanced Lymphatic Uptake
|
5 Participants
|
5 Participants
|
|
Lymph Movement Measured by ICG Lymphography.
Lymph Movement after Single Treatment · No Enhanced Lymphatic Uptake
|
0 Participants
|
0 Participants
|
|
Lymph Movement Measured by ICG Lymphography.
Lymph Movement after 2 Weeks of Treatment · Enhanced Lymphatic Uptake
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Single Treatment, 2 Weeks of TreatmentPopulation: The analysis population included all enrolled subjects who completed the study and properly used the device. One subject reported wearing the head garment upside down during the two week treatment period, therefore the subject was excluded from the analysis population for a cohort of 10 analyzable data sets.
Resolves dermal backflow as measured by ICG lymphography. A positive change in area indicates an increase in observable abnormal lymphatics, while a negative change indicates a decrease in observable abnormal lymphatics. A positive increase after a single treatment is expected as the manual stimulation of the lymphatics promotes the movement of ICG through the lymphatic space; however, a decrease over time provides an indication of improved lymphatic recovery.
Outcome measures
| Measure |
Pneumatic Compression-1 Session Per Day
n=5 Participants
Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).
Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.
|
Pneumatic Compression-2 Sessions Per Day
n=5 Participants
Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).
Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.
|
|---|---|---|
|
Dermal Backflow Measured by ICG Lymphography.
Dermal Backflow after Single Treatment) · No Dermal Backflow/No Change
|
1 Participants
|
1 Participants
|
|
Dermal Backflow Measured by ICG Lymphography.
Dermal Backflow after Single Treatment) · Positive Change in Area
|
4 Participants
|
4 Participants
|
|
Dermal Backflow Measured by ICG Lymphography.
Dermal Backflow after Single Treatment) · Negative Change in Area
|
0 Participants
|
0 Participants
|
|
Dermal Backflow Measured by ICG Lymphography.
Dermal Backflow after 2 Weeks of Treatments · Positive Change in Area
|
1 Participants
|
1 Participants
|
|
Dermal Backflow Measured by ICG Lymphography.
Dermal Backflow after 2 Weeks of Treatments · Negative Change in Area
|
3 Participants
|
3 Participants
|
|
Dermal Backflow Measured by ICG Lymphography.
Dermal Backflow after 2 Weeks of Treatments · No Dermal Backflow/No Change
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Single Treatment, 2 Weeks of TreatmentPopulation: The analysis population included all enrolled subjects who completed the study and properly used the device. One subject reported wearing the head garment upside down during the two week treatment period, therefore the subject was excluded from the analysis population for a cohort of 10 analyzable data sets.
Alleviates lymphedema symptoms as measured by survey response.
Outcome measures
| Measure |
Pneumatic Compression-1 Session Per Day
n=5 Participants
Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).
Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.
|
Pneumatic Compression-2 Sessions Per Day
n=5 Participants
Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).
Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.
|
|---|---|---|
|
Symptom Alleviation Measured by Survey Response.
After 2 Weeks of Treatment · Data Missing
|
0 Participants
|
1 Participants
|
|
Symptom Alleviation Measured by Survey Response.
After Single Treatment · Felt much better
|
0 Participants
|
2 Participants
|
|
Symptom Alleviation Measured by Survey Response.
After Single Treatment · Felt somewhat better
|
4 Participants
|
2 Participants
|
|
Symptom Alleviation Measured by Survey Response.
After Single Treatment · Felt about the same
|
1 Participants
|
1 Participants
|
|
Symptom Alleviation Measured by Survey Response.
After Single Treatment · Data Missing
|
0 Participants
|
0 Participants
|
|
Symptom Alleviation Measured by Survey Response.
After 2 Weeks of Treatment · Felt much better
|
0 Participants
|
0 Participants
|
|
Symptom Alleviation Measured by Survey Response.
After 2 Weeks of Treatment · Felt somewhat better
|
2 Participants
|
4 Participants
|
|
Symptom Alleviation Measured by Survey Response.
After 2 Weeks of Treatment · Felt about the same
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Single Treatment, 2 Weeks of TreatmentPopulation: The analysis population included all enrolled subjects who completed the study and properly used the device. One subject reported wearing the head garment upside down during the two week treatment period, therefore the subject was excluded from the analysis population for a cohort of 10 analyzable data sets.
Flexitouch is easy to use as measured by survey responses.
Outcome measures
| Measure |
Pneumatic Compression-1 Session Per Day
n=5 Participants
Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).
Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.
|
Pneumatic Compression-2 Sessions Per Day
n=5 Participants
Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).
Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.
|
|---|---|---|
|
Ease of Use Measured by Survey Response.
Ability to Don after Single Treatment · Independently
|
1 Participants
|
1 Participants
|
|
Ease of Use Measured by Survey Response.
Ability to Don after Single Treatment · Minimal Assist
|
4 Participants
|
4 Participants
|
|
Ease of Use Measured by Survey Response.
Ability to Don after Single Treatment · Data Missing
|
0 Participants
|
0 Participants
|
|
Ease of Use Measured by Survey Response.
Ability to Don after 2 Weeks of Treatment · Independently
|
4 Participants
|
4 Participants
|
|
Ease of Use Measured by Survey Response.
Ability to Don after 2 Weeks of Treatment · Minimal Assist
|
1 Participants
|
0 Participants
|
|
Ease of Use Measured by Survey Response.
Ability to Don after 2 Weeks of Treatment · Data Missing
|
0 Participants
|
1 Participants
|
|
Ease of Use Measured by Survey Response.
Ability to Doff after Single Treatment · Independently
|
4 Participants
|
3 Participants
|
|
Ease of Use Measured by Survey Response.
Ability to Doff after Single Treatment · Minimal Assist
|
1 Participants
|
1 Participants
|
|
Ease of Use Measured by Survey Response.
Ability to Doff after Single Treatment · Data Missing
|
0 Participants
|
1 Participants
|
|
Ease of Use Measured by Survey Response.
Ability to Doff after 2 Weeks of Treatment · Independently
|
4 Participants
|
3 Participants
|
|
Ease of Use Measured by Survey Response.
Ability to Doff after 2 Weeks of Treatment · Minimal Assist
|
1 Participants
|
0 Participants
|
|
Ease of Use Measured by Survey Response.
Ability to Doff after 2 Weeks of Treatment · Data Missing
|
0 Participants
|
2 Participants
|
Adverse Events
Pneumatic Compression-1 Session Per Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pneumatic Compression-2 Sessions Per Day
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pneumatic Compression-1 Session Per Day
n=6 participants at risk
Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).
Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.
|
Pneumatic Compression-2 Sessions Per Day
n=5 participants at risk
Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).
Head and neck garments for pneumatic compression device.: Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
NIRFLI with ICG: Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.
|
|---|---|---|
|
Nervous system disorders
Pain/Discomfort
|
0.00%
0/6 • Adverse events were collected from enrollment through study exit which was equivalent to approximately two weeks.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from enrollment through study exit which was equivalent to approximately two weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Adverse events were collected from enrollment through study exit which was equivalent to approximately two weeks.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from enrollment through study exit which was equivalent to approximately two weeks.
|
|
Infections and infestations
Infection (fungal)
|
0.00%
0/6 • Adverse events were collected from enrollment through study exit which was equivalent to approximately two weeks.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from enrollment through study exit which was equivalent to approximately two weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60