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

NCT03558672 | Terminated Results FDA Device

• 1 other identifier: 4060
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 4

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.

Conditions

Head and Neck Lymphedema

Keywords

Flexitouch

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Changes in Health-related Quality of Life From Baseline to 6 Months

  Percent Changes between Baseline and 6 months will be assessed

• Changes in Health-related Quality of Life-Overall From Baseline to 6 Months

  Percent Changes between Baseline and 6 months will be assessed

• Changes in Pain From Baseline to 6 Months

  Percent Changes between Baseline and 6 months will be assessed

• Change in Swelling From Baseline to 6 Months

  Percent Changes between Baseline and 6 months will be assessed

• Ease of Use/Satisfaction

  Assessed at 6 months

Interventions

Flexitouch system with Head and Neck Garments DEVICE

Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tactile Medical: lead

Study Sites (4)

Iowa ENT Center

West Des Moines, Iowa, 50265, United States

Location

Charles George VA Medical Center

Asheville, North Carolina, 28805, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Limitations and Caveats

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.

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Tactile Medical

astone@tactilemedical.com

612.540.5267

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: June 15, 2018
• Study Start: September 14, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: September 2, 2020
• Results First Posted: August 18, 2020

Record last verified: 2020-08

Locations

US (4)