[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07613931":3,"trial-entities:NCT07613931":96,"trial-summary:NCT07613931":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":45,"secondary_outcomes":53,"sex":63,"minimum_age":64,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":65,"std_ages":69,"locations":72,"central_contacts":88,"overall_officials":93,"references":94,"see_also_links":95},"NCT07613931","7010","Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment","A Pilot Study to Evaluate and Compare Lymphatic Transport in Patients With Lower Extremity Lymphedema Between Flexitouch Plus® and Flexitouch Plus® With Novel Multi-Chamber Firmware","RECRUITING","2026-09","2026-07","2026-07-08","Tactile Medical","INDUSTRY",false,"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:\n\n• Does the revised method of compression improve lymph movement and lymphatic propulsion?",null,[18],"Lower Extremity Lymphedema",[20,21],"lymphedema","lower extremity","INTERVENTIONAL","DEVICE_FEASIBILITY",[25],"EARLY_PHASE1",{"count":27,"type":28},5,"ESTIMATED",[30,36,40],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","Advanced pneumatic compression device (APCD)","Single APCD treatment session at visit 1",[35],"Treatment group",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Advanced pneumatic compression device (APCD) with revised compression programming","APCD with revised compression programming will be single treatment session at visit 2",[35],{"type":41,"name":42,"description":43,"armGroupLabels":44},"DRUG","Indocyanine Green (IC-Green)","Indocyanine Green dye will be used to assess primary endpoint",[35],[46,50],{"measure":47,"description":48,"timeFrame":49},"Lymphatic anatomy","• The distance (cm) that lymph travels from injection sites","Before and after 60-minute treatment in clinic with APCD",{"measure":51,"description":52,"timeFrame":49},"Lymphatic propulsion","• Number of lymph propulsion events per minute",[54,57,59],{"measure":55,"description":56,"timeFrame":49},"Evaluate swelling in treatment limbs","• Changes in leg circumferential measurements (cm)",{"measure":55,"description":58,"timeFrame":49},"Change in local water content (ratio of % water content in legs to reference site)",{"measure":60,"description":61,"timeFrame":62},"Adverse Events","• Adverse Event assessments","Through completion of study at Visit 2, up to 4 weeks","ALL","18 Years",{"inclusion":66,"exclusion":67,"raw_text":68},[],[],"Inclusion Criteria:\n\n1. 18 years of age or older\n2. A diagnosis of active lower extremity lymphedema, as assessed by medical history\n3. Participant is a candidate for APCD treatment per the Flexitouch Plus indications for use\n4. Must be able to provide informed consent prior to study participation\n5. Willing and able to comply with the study protocol requirements and all study-related visit requirements\n\nExclusion Criteria:\n\n1. Heart failure (acute pulmonary edema, decompensated acute heart failure)\n2. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)\n3. Severe peripheral artery disease (critical limb ischemia, including ischemic rest pain, arterial wounds or gangrene)\n4. Active skin or limb infection\u002Finflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the trunk or lower extremities\n5. Active cancer or metastasis in the lower extremity lymphatic watersheds\n6. Eczema, rash, scarring, or extensive tattoos at imaging sites\n7. Participant is pregnant or trying to become pregnant\n8. Participants with a history of allergy to iodides, who may be susceptible to iodine present in ICG formulation\n9. Patients exhibiting Grade 3 or higher on the CTCAE v6.0 superficial soft tissue fibrosis scale\n10. Body Mass Index (BMI) ≥40\n11. 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",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":74,"status":8,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":85},"UTHealth Houston (The University of Texas Health Science Center at Houston)","Houston","Texas","77030","United States",[80],{"name":81,"role":82,"phone":83,"email":84},"John Rasmussen, PhD","CONTACT","713-500-3393","John.Rasmussen@uth.tmc.edu",{"lat":86,"lon":87},29.76328,-95.36327,[89],{"name":90,"role":82,"phone":91,"email":92},"Senior Vice President Marketing and Market Access","1.833.382.2845","clinicalresearch@tactilemedical.com",[],[],[],{"nct_id":4,"conditions":97,"biomarkers":99},[98],"Lymphedema of lower extremity",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study with a planned enrollment of 5 participants. It compares a single session of the current APCD treatment with a single session using revised compression programming.","completed","Advanced Pneumatic Compression for Lymphedema","This study is looking at a new way to use an advanced pneumatic compression device (APCD) to treat lower extremity lymphedema (swelling in the legs). Researchers want to see if a revised compression program works better than the current method to improve how your lymphatic system moves fluid. They will use Indocyanine Green (IC-Green) dye to measure changes in your lymphatic system. You may be able to join if you are 18 or older, have lower extremity lymphedema, and are a candidate for APCD treatment. The study is currently unclear on its recruitment status.","Lymphatic anatomy and propulsion will be measured before and after each 60-minute treatment session.",94,"You would have two in-clinic treatment sessions, each lasting 60 minutes. Indocyanine Green dye will be used to assess your lymphatic system before and after each treatment.","Not stated in the trial record.",[32,42],"v2"]