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Low enrollment numbers
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The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexitouch system with Head and Neck Garments | Device | Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom/Problem Improvement From Baseline to 6 Months | To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Positive value shows an increase in symptoms/problems. Negative value shows a decrease in symptoms/problems. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. | Percent Changes between Baseline and 6 months will be assessed |
| Function (Range of Motion) Improvement From Baseline to 6 Months | To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Positive value shows an increase in Function/Range of Motion. Negative value shows a decrease in Function/Range of Motion. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. | Percent Changes between Baseline and 6 months will be assessed |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Health-related Quality of Life From Baseline to 6 Months | Subject Quality of Life will be assessed using EORTC C30 questionnaire. Positive value shows an decrease in quality of life. Negative value shows a increase in quality of life. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. | Percent Changes between Baseline and 6 months will be assessed |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects diagnosed with Head and Neck Lymphedema and prescribed the Flexitouch system or Flexitouch Plus system as standard of care treatment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa ENT Center | West Des Moines | Iowa | 50265 | United States | ||
| Charles George VA Medical Center |
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Participants were recruited among therapists and physicians across 4 US sites between September 2018 and March 2020. The first subject was enrolled on September 14, 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population includes subjects who completed the screening process. This does not include screen failure subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Symptom/Problem Improvement From Baseline to 6 Months | To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Positive value shows an increase in symptoms/problems. Negative value shows a decrease in symptoms/problems. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. | Although 8 participants had completed the study, only 7 completed all required questionnaires. Therefore, the analysis population only includes the 7 participants who completed the required questionnaires throughout the study. | Posted | Number | percent change in score | Percent Changes between Baseline and 6 months will be assessed |
|
Adverse events were collected on participants who received and were trained on the device from the 2 week visit until 6 month visit or study exit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Participants received either the Flexitouch system or Flexitouch Plus Head and Neck treatment, as prescribed. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
This study was prematurely terminated in regards to slow enrollment; there were no safety issues presented. The variability in the small N (N=8) provide inconclusive evidence and non analyzable outcome measure from this incomplete data cohort.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Tactile Medical | 612.540.5267 | astone@tactilemedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2019 | Jul 3, 2020 | Prot_SAP_000.pdf |
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| Changes in Health-related Quality of Life-Overall From Baseline to 6 Months | Subject overall health and quality of life in the past week-EORTC C30. Positive value shows an increase in quality of life/overall health. Negative value shows a decrease in quality of life/overall health. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. | Percent Changes between Baseline and 6 months will be assessed |
| Changes in Pain From Baseline to 6 Months | Pain will be assessed using the VAS Pain Scale. Positive value shows an increase in pain. Negative value shows a decrease in pain. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. | Percent Changes between Baseline and 6 months will be assessed |
| Change in Swelling From Baseline to 6 Months | Swelling will be assessed using the ALOHA measurement protocol. Positive value shows an increase in swelling. Negative value shows a decrease in swelling. Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. | Percent Changes between Baseline and 6 months will be assessed |
| Ease of Use/Satisfaction | Both Ease of Use/Satisfaction will be assessed by survey. Percentage of each response captured. | Assessed at 6 months |
| Asheville |
| North Carolina |
| 28805 |
| United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
|
|
| Primary | Function (Range of Motion) Improvement From Baseline to 6 Months | To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Positive value shows an increase in Function/Range of Motion. Negative value shows a decrease in Function/Range of Motion. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. | Analysis includes the 8 participants who completed the study required visits and assessments. | Posted | Number | percent change in measurement | Percent Changes between Baseline and 6 months will be assessed |
|
|
|
| Secondary | Changes in Health-related Quality of Life From Baseline to 6 Months | Subject Quality of Life will be assessed using EORTC C30 questionnaire. Positive value shows an decrease in quality of life. Negative value shows a increase in quality of life. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. | Although 8 participants had completed the study, only 7 completed all required questionnaires. Therefore, the analysis population only includes the 7 participants who completed the required questionnaires throughout the study. | Posted | Number | percent change in score | Percent Changes between Baseline and 6 months will be assessed |
|
|
|
| Secondary | Changes in Health-related Quality of Life-Overall From Baseline to 6 Months | Subject overall health and quality of life in the past week-EORTC C30. Positive value shows an increase in quality of life/overall health. Negative value shows a decrease in quality of life/overall health. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. | Although 8 participants had completed the study, only 7 completed all required questionnaires. Therefore, the analysis population only includes the 7 participants who completed the required questionnaires throughout the study. | Posted | Number | % change from baseline to 6 months | Percent Changes between Baseline and 6 months will be assessed |
|
|
|
| Secondary | Changes in Pain From Baseline to 6 Months | Pain will be assessed using the VAS Pain Scale. Positive value shows an increase in pain. Negative value shows a decrease in pain. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. | Although 8 participants had completed the study, only 7 completed all required questionnaires. Therefore, the analysis population only includes the 7 participants who completed the required questionnaires throughout the study. | Posted | Number | percent change in score | Percent Changes between Baseline and 6 months will be assessed |
|
|
|
| Secondary | Change in Swelling From Baseline to 6 Months | Swelling will be assessed using the ALOHA measurement protocol. Positive value shows an increase in swelling. Negative value shows a decrease in swelling. Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. | Analysis includes the 8 participants who completed the study required visits and assessments. | Posted | Number | percent change in swelling measurements | Percent Changes between Baseline and 6 months will be assessed |
|
|
|
| Secondary | Ease of Use/Satisfaction | Both Ease of Use/Satisfaction will be assessed by survey. Percentage of each response captured. | Although 8 participants had completed the study, only 7 completed all required questionnaires. Therefore, the analysis population only includes the 7 participants who completed the required questionnaires throughout the study. | Posted | Number | percent of participants | Assessed at 6 months |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 3 |
| 18 |
| Dry Skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
|
| Lingual villosa | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Osteomylelitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Cervical: Left Lateral |
|
| Cervical: Right Rotation |
|
| Cervical: Left Rotation |
|
| Shoulder: Right Flexion |
|
| Shoulder: Right Abduction |
|
| Shoulder: Left Flexion |
|
| Shoulder: Left Abduction |
|
| Mouth: Open |
|
| Title | Measurements |
|---|---|
|
| Do you need to stay in bed or a chair during day? |
|
| Do you need help eating, dressing, washing? |
|
| Were you limited in work or other day activities? |
|
| Were you limited in hobbies or leisure activities? |
|
| Were you short of breath? |
|
| Have you had pain? |
|
| Did you need to rest? |
|
| Have you had trouble sleeping? |
|
| Have you felt weak? |
|
| Have you lacked appetite? |
|
| Have you felt nauseated? |
|
| Have you vomited? |
|
| Have you been constipated? |
|
| Have you had diarrhea? |
|
| Were you tired? |
|
| Did pain interfere with daily activities? |
|
| Have you had difficulty concentrating? |
|
| Did you feel tense? |
|
| Did you worry? |
|
| Did you feel Irritable? |
|
| Did you feel depressed? |
|
| Have you had difficulty remembering things? |
|
| Has condition/treatment interfered with family? |
|
| Has condition/treatment interfered socially? |
|
| Has condition/treatment caused difficult finances? |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Easy to use Flexitouch garments |
|
| Very easy to use Flexitouch garments |
|
| Very difficult to use Flexitouch controller |
|
| Difficult to use Flexitouch controller |
|
| Neither easy nor difficult-Flexitouch controller |
|
| Easy to use Flexitouch controller |
|
| Very easy to use Flexitouch controller |
|
| Very uncomfortable treatment by Flexitouch system |
|
| Uncomfortable treatment by Flexitouch system |
|
| Neither uncomfortable nor comfortable treatment |
|
| Comfortable treatment by Flexitouch system |
|
| Very comfortable treatment by Flexitouch system |
|
| Very dissatisfied overall with Flexitouch system |
|
| Dissatisfied overall with Flexitouch system |
|
| Neither dissatisfied nor satisfied overall |
|
| Satisfied overall with Flexitouch system |
|
| Very satisfied overall with Flexitouch system |
|
| Yes, would recommend Flexitouch system to others |
|
| No,would not recommend Flexitouch system to others |
|