Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03558672
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Tactile Medical

Brief Summary:
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.

Condition or disease Intervention/treatment
Head and Neck Lymphedema Device: Flexitouch system with Head and Neck Garments

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema
Actual Study Start Date : September 6, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema


Intervention Details:
  • Device: Flexitouch system with Head and Neck Garments
    Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed


Primary Outcome Measures :
  1. Symptom Improvement [ Time Frame: Changes between Baseline and 6 months will be assessed ]
    To evaluate symptoms based upon the EORTC HN35 questionnaire after 168 days (approximately 6 months) of treatment with the Flexitouch System or Flexitouch Plus

  2. Function Improvement [ Time Frame: Changes between Baseline and 6 months will be assessed ]
    To evaluate function based upon cervical and shoulder range of motions measurements after 168 days (approximately 6 months) of treatment with the Flexitouch System or Flexitouch Plus


Secondary Outcome Measures :
  1. Changes in health-related Quality of Life [ Time Frame: Changes between Baseline and 1, 3, and 6 months will be assessed ]
    Subject Quality of Life will be assessed using EORTC C30 questionnaire

  2. Changes in Pain [ Time Frame: Changes between Baseline and 1, 3, and 6 months will be assessed ]
    Pain will be assessed using the VAS Pain Scale

  3. Change in Swelling [ Time Frame: Changes between Baseline and 1, 3, and 6 months will be assessed ]
    Swelling will be assessed using the ALOHA measurement protocol

  4. Ease of Use and Treatment Satisfaction [ Time Frame: Assessed at 6 months ]
    Both Ease of Use and Treatment satisfaction will be assessed by survey



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects diagnosed with Head and Neck Lymphedema and prescribed the Flexitouch system or Flexitouch Plus system as standard of care treatment
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672


Contacts
Layout table for location contacts
Contact: Jill Christensen 612-355-5123 jchristensen@tactilemedical.com

Locations
Layout table for location information
United States, North Carolina
Charles George VA Medical Center Recruiting
Asheville, North Carolina, United States, 28805
Contact: Leslie Peyton    828-298-7911    leslie.peyton@va.gov   
Principal Investigator: Julia Furdyna, MD         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Brandi Lemon    614-685-8964    brandi.lemon@osumc.edu   
Principal Investigator: Stephen Kang, MD         
Sponsors and Collaborators
Tactile Medical

Additional Information:

Layout table for additonal information
Responsible Party: Tactile Medical
ClinicalTrials.gov Identifier: NCT03558672     History of Changes
Other Study ID Numbers: 4060
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Tactile Medical:
Flexitouch

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphedema
Lymphatic Diseases