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West Des Moines, Iowa 50265

  • Head and Neck Lymphedema

Purpose:

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.


Criteria:

Inclusion Criteria: - Age ≥ 18 years - A diagnosis of head and/or neck lymphedema - Must be able and willing to participate in all aspects of the registry and provide informed consent prior to registry participation - Head and chest measurements within the following: - Crown of head circumference: ≤ 72 cm - Chest circumference: ≤ 158 cm - Prescribed the Flexitouch system or Flexitouch Plus Exclusion Criteria: - Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression) - Carotid sinus hypersensitivity syndrome - Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness) - Symptomatic bradycardia in the absence of a pacemaker - Internal jugular venous thrombosis (within 3 months) - Increased intracranial pressure or other contraindications to internal or external jugular venous compression - Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), or surgical flap less than 6-8 weeks post-operative - Facial or head and neck dermal metastasis - Acute facial infection (e.g., facial or parotid gland abscess) - Any condition in which increased venous and lymphatic return is undesirable - Heart failure (acute pulmonary edema, decompensated acute heart failure) - Subject is pregnant or trying to become pregnant - Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)


Study is Available At:


Original ID:

4060


NCT ID:

NCT03558672


Secondary ID:


Study Acronym:


Brief Title:

A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema


Official Title:

A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Tactile Medical


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:

Low enrollment numbers


Study Type:

Observational [Patient Registry]


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Study Dates

Start Date:September 14, 2018
Completion Date:May 1, 2020
Completion Type:Actual
Primary Completion Date:May 1, 2020
Primary Completion Type:Actual
Verification Date:August 2020
Last Changed Date:August 20, 2020
First Received Date:May 10, 2018
First Results Date:June 12, 2020

Study Outcomes

Outcome Type:Primary Outcome
Measure:Symptom/Problem Improvement From Baseline to 6 Months
Time Frame:Percent Changes between Baseline and 6 months will be assessed
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Function (Range of Motion) Improvement From Baseline to 6 Months
Time Frame:Percent Changes between Baseline and 6 months will be assessed
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Changes in Health-related Quality of Life From Baseline to 6 Months
Time Frame:Percent Changes between Baseline and 6 months will be assessed
Safety Issues:False
Description: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 mo
Outcome Type:Secondary Outcome
Measure:Changes in Health-related Quality of Life-Overall From Baseline to 6 Months
Time Frame:Percent Changes between Baseline and 6 months will be assessed
Safety Issues:False
Description: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 be
Outcome Type:Secondary Outcome
Measure:Changes in Pain From Baseline to 6 Months
Time Frame:Percent Changes between Baseline and 6 months will be assessed
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Change in Swelling From Baseline to 6 Months
Time Frame:Percent Changes between Baseline and 6 months will be assessed
Safety Issues:False
Description: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 ve
Outcome Type:Secondary Outcome
Measure:Ease of Use/Satisfaction
Time Frame:Assessed at 6 months
Safety Issues:False
Description:Both Ease of Use/Satisfaction will be assessed by survey. Percentage of each response captured.

Study Interventions

Intervention Type:Device
Name:Flexitouch system with Head and Neck Garments
Description:Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Tactile Medical

Samples and Retentions

Study Population: Subjects diagnosed with Head and Neck Lymphedema and prescribed the Flexitouch system or Flexitouch Plus system as standard of care treatment
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


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