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Pneumatic Compression Device

Advanced Pneumatic Compression Device for Lymphedema

N/A
Recruiting
Led By Barbara Murphy, MD
Research Sponsored by Tactile Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes between baseline, 2 months, 4 months, 6 months
Awards & highlights

Study Summary

This trial is testing whether a new type of care for lymphedema and fibrosis (LEF) is better than the usual care for head and neck cancer (HNC) survivors.

Eligible Conditions
  • Lymphedema
  • Facial Lymphedema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes between baseline, 2 months, 4 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and changes between baseline, 2 months, 4 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body image - Body Image Quality of Life Inventory (BIQLI)
Diet modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
Perceived self-management capacity - Perceived Medical Condition Self-Management Scale (PMCSMS)
+8 more

Trial Design

2Treatment groups
Active Control
Group I: Advanced Pneumatic Compression Device (APCD)Active Control1 Intervention
Daily self-administered treatment with the Flexitouch® Plus system (FT)
Group II: Usual CareActive Control1 Intervention
Complete Decongestive Therapy (CDT) directed by a lymphedema therapist and any additional adjunctive measures as prescribed by the lymphedema therapist

Find a Location

Who is running the clinical trial?

Tactile MedicalLead Sponsor
15 Previous Clinical Trials
903 Total Patients Enrolled
12 Trials studying Lymphedema
738 Patients Enrolled for Lymphedema
Vanderbilt University Medical CenterOTHER
856 Previous Clinical Trials
671,942 Total Patients Enrolled
3 Trials studying Lymphedema
129 Patients Enrolled for Lymphedema
Barbara Murphy, MDPrincipal InvestigatorVanderbilt University Medical Center
14 Previous Clinical Trials
1,934 Total Patients Enrolled

Media Library

Advanced Pneumatic Compression Device (Pneumatic Compression Device) Clinical Trial Eligibility Overview. Trial Name: NCT04797390 — N/A
Lymphedema Research Study Groups: Advanced Pneumatic Compression Device (APCD), Usual Care
Lymphedema Clinical Trial 2023: Advanced Pneumatic Compression Device Highlights & Side Effects. Trial Name: NCT04797390 — N/A
Advanced Pneumatic Compression Device (Pneumatic Compression Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04797390 — N/A
Lymphedema Patient Testimony for trial: Trial Name: NCT04797390 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cohort size of this clinical experiment?

"To properly undertake this medical trial, Tactile Medical requires 250 suitable participants. To facilitate recruitment and treatment, Johns Hopkins University in Baltimore and Karmanos Cancer Institute in Detroit have both been selected as clinical sites."

Answered by AI

Is the door open to new participants in this healthcare experiment?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical experiment is actively recruiting individuals who meet the eligibility criteria. Initially posted on September 23rd 2021, it has most recently been updated on November 14th 2022 and requires 250 participants from 8 sites across the United States of America."

Answered by AI

In how many different precincts is this research study being managed?

"Eight sites are currently enrolling participants in this study, including the Johns Hopkins University of Baltimore, Karmanos Cancer Institute of Detroit and Advanced Head & Neck Rehabilitation Center of Texas in Fort Worth. Additional locations exist as well."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Maryland
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
0
What site did they apply to?
Vanderbilt University Medical Center

Why did patients apply to this trial?

I have Lymphedema in my left leg , I am and I. I want to find alternative ways to live with the disease.
PatientReceived no prior treatments
I have Lymphedema in my let leg and I am desperate to find a cure or contrrol it!
PatientReceived 1 prior treatment
I have Lymphedema in my left leg , I am always looking for ways to improve my condition.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long is the trial and does it involve medication?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
2021. "A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04797390.
All > Lymphedema
~70 spots leftby Apr 2025
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