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RecruitingEarly Phase 1

Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment

Tactile Medical · NCT07613931

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Early Phase 1
Target enrollment
5
US sites recruiting
1
Study start
July 9, 2026
Record last updated
August 11, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The goal of this pilot study is to learn if a revised method of compression improves lymphatic function compared to the current method of compression. The main questions:

  • Does the revised method of compression improve lymph movement and lymphatic propulsion?

Being studied: Advanced pneumatic compression device (APCD); Advanced pneumatic compression device (APCD) with revised compression programming; Indocyanine Green (IC-Green)

Conditions: Lower Extremity Lymphedema

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 18 years of age or older
  • A diagnosis of active lower extremity lymphedema, as assessed by medical history
  • Participant is a candidate for APCD treatment per the Flexitouch Plus indications for use
  • Must be able to provide informed consent prior to study participation
  • Willing and able to comply with the study protocol requirements and all study-related visit requirements

Exclusion Criteria

  • Heart failure (acute pulmonary edema, decompensated acute heart failure)
  • Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
  • Severe peripheral artery disease (critical limb ischemia, including ischemic rest pain, arterial wounds or gangrene)
  • Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the trunk or lower extremities
  • Active cancer or metastasis in the lower extremity lymphatic watersheds
  • Eczema, rash, scarring, or extensive tattoos at imaging sites
  • Participant is pregnant or trying to become pregnant
  • Participants with a history of allergy to iodides, who may be susceptible to iodine present in ICG formulation
  • Patients exhibiting Grade 3 or higher on the CTCAE v6.0 superficial soft tissue fibrosis scale
  • Body Mass Index (BMI) ≥40
  • Participants unable to recline on their backs for up to 60 consecutive minutes and walk in place or tolerate assisted lower extremity movement for 5 minutes

Recruiting US locations

  • UTHealth Houston (The University of Texas Health Science Center at Houston)

    Houston, TX 77030

    Site contact: John Rasmussen, PhD · 713-500-3393 · John.Rasmussen@uth.tmc.edu

Study contacts (from the official record)

  • Senior Vice President Marketing and Market Access · 1.833.382.2845 · clinicalresearch@tactilemedical.com
All phase 1 studies in Texas →
Evaluate Advanced Pneumatic Compression Device With Revised… (NCT07613931) | Bored Studies