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NCT03558672 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Tactile Medical.

Terminated
Registry status
18
Enrollment target

NCT03558672: Clinical Trial study, sponsored by Tactile Medical.

NCT03558672 is a clinical trial that was terminated before completion, run by Tactile Medical. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03558672 was terminated before completion, sponsored by Tactile Medical.

TERMINATED
Registry status
18 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DEVICE Flexitouch system with Head and Neck Garments

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2018-09-14
Est. Completion 2020-05-01
Tactile Medical

14 total trials

Why NCT03558672 stopped before completion

NCT03558672 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 18 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Flexitouch system with Head and Neck Garments is the first listed.

NCT03558672 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03558672 about?

NCT03558672 is a clinical study titled "A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema". 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), ...

What is the current status of trial NCT03558672?

This trial is currently terminated. The enrollment target is 18 participants. The study started on 2018-09-14. Estimated completion is 2020-05-01.

What interventions are being tested in trial NCT03558672?

The interventions under investigation include: Flexitouch system with Head and Neck Garments (DEVICE).

Who is sponsoring clinical trial NCT03558672?

This trial is sponsored by Tactile Medical, which has 14 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03558672, the US trial registry maintained by the National Library of Medicine. NCT03558672 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.