Clinical trials: Effects of Heat
Advanced Solid Tumor
A Phase 1 Study of HS130 in Combination With Viagenpumatucel-L (HS110) in Patients With Solid Tumors
This is a phase 1 open-label, single center, dose escalation study to determine a safe and effective maximum tolerated dose of HS-130 in combination with viagenpumatucel-L (HS-110) for adult subjects with advanced solid tumors…
- Trial name
- NCT04116710
- Testing
- HS-110 (viagenpumatucel-L), HS-130
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Heat Biologics
Macromastia
A Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0
The objective of this clinical study is to evaluate scar quality following incision with the PEAK PlasmaBlade 4.0 using the Patient and Observer Scar Assessment Scale (POSAS), and to compare these results to equivalently-aged…
- Trial name
- PRECISE (NCT01284491)
- Testing
- PEAK PlasmaBlade 4.0, Traditional Electrosurgery with scalpel
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Medtronic Surgical Technologies
Exertional Heat Stroke
Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS
A double-blind, parallel study of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) compared to current Standard of Care (SOC) for EHS.
- Trial name
- NCT03600376
- Testing
- Ryanodex and Standard of Care, Standard of Care
- Where
- 4 sites in Saudi Arabia
- Volunteers
- 17 people
- Sponsor
- Eagle Pharmaceuticals, Inc.
Chronic Pain, Low Back Pain
High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain
This study is a double blinded randomized active placebo controlled trial in subjects with chronic low back pain. The trial compares pain relief by a device that delivered high level pulsed heat (45 °C) to pain relief delivered…
- Conditions
- Chronic Pain, Low Back Pain, Heat, Analgesia
- Trial name
- NCT04109703
- Testing
- High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc., Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc.
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Soovu Labs Inc.
Knee Osteoarthritis
Wearable LITUS Device for Osteoarthritis of the Knee: a Randomized Double-Blind Placebo-Controlled Trial
The purpose of this study is to measure the effectiveness of a wearable therapeutic ultrasound device in patients with stage I and stage II knee osteoarthritis.
- Trial name
- NCT02083861
- Testing
- Sam Ultrasonic Diathermy Device
- Where
- United States
- Volunteers
- 93 people
- Sponsor
- ZetrOZ, Inc.
Amputation, Amputation; Traumatic, Leg, Lower
Socket Cooling Effectiveness Take Home Study
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Amputation Stump, Limb; Absence, Congenital, Lower
- Trial name
- NCT04484805
- Testing
- ICE Condition
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Bladder Cancer
A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT
Phase I/II study: Phase 1 is an open-label, safety study, patients who previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose…
- Trial name
- NCT02010203
- Testing
- HS-410, BCG
- Where
- 19 sites in United States
- Volunteers
- 104 people
- Sponsor
- Heat Biologics
HIV Infection
Abacavir/Lamivudine Versus Emtricitabine/Tenofovir Both In Combination With Lopinavir/Ritonavir For The Treatment Of HIV
This study was designed to test the safety and effectiveness of EPZICOM(abacavir/lamivudine) and TRUVADA (emtricitabine/tenofovir) for the treatment of HIV infection when both are used in combination with KALETRA…
- Trial name
- HEAT (NCT00244712)
- Testing
- emtricitabine/tenofovir, abacavir/lamivudine
- Where
- 74 sites in United States, Puerto Rico
- Volunteers
- 688 people
- Sponsor
- GlaxoSmithKline
Macromastia
PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following…
- Trial name
- PRECISE (NCT00986453)
- Testing
- PEAK PlasmaBlade, Traditional Electrosurgery with scalpel
- Where
- 7 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Medtronic Surgical Technologies
Herpes Zoster, Herpes Zoster-related Complications
A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002)
This study will evaluate the safety and immunogenicity of a heat-treated VZV vaccine in autologous or allogeneic hematopoietic cell transplant (HCT) recipients, human immunodeficiency virus (HIV)-infected participants with a…
- Trial name
- NCT00535236
- Testing
- V212
- Volunteers
- 341 people
- Sponsor
- Merck Sharp & Dohme LLC
Tracheostomy
Clinical Assessment of New Speaking Valve With Heat and Moisture Exchanger (HME) for Tracheotomized Patients
This clinical investigation addresses the performance of a re-designed The current study aims to investigate the next version of the TW speaking valve, in combination with both a 15mm and 22mm HME cassette.
- Trial name
- NCT01976819
- Testing
- TW speaking valve/HME
- Where
- Netherlands
- Volunteers
- 16 people
- Sponsor
- Atos Medical AB
Amputation Stumps, Amputees
Moisture Management Liner Effectiveness Study
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm…
- Conditions
- Amputation Stumps, Amputees, Amputation, Lower Limb Deformities, Congenital
- Trial name
- NCT04427007
- Testing
- Moisture Management Liner, Control Liner
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Solid Tumors, Non-small Cell Lung Carcinoma
A Study of DS-2248 in Participants With Advanced Solid Tumors
This phase 1 clinical trial is intended to understand the safety and tolerability of a new anticancer drug in subjects with advanced solid tumors.
- Trial name
- NCT01288430
- Testing
- DS-2248
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Daiichi Sankyo
Breast Cancer
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy
The purpose of this clinical study is to quantify the difference in thermal injury depth at the surgical margin in breast lumpectomy specimens excised with the PlasmaBlade; to subjectively assess histopathologic sample quality…
- Trial name
- PRECISE (NCT00960154)
- Testing
- PEAK PlasmaBlade, Traditional Electrosurgery with scalpel
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Surgical Technologies
Elastosis
PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty
The objective of this clinical study is to evaluate healing of incisions made with the PEAK PlasmaBlade 4.0 compared to scalpel and traditional electrosurgery (Bovie); to monitor and record key post-operative metrics following…
- Trial name
- PRECISE (NCT00943150)
- Testing
- PEAK PlasmaBlade, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medtronic Surgical Technologies
Herpes Zoster
A Study to Evaluate Immunity to Varicella Zoster Virus After Immunization With V212 Vaccine or Zostavax (V212-003)
A study in two parts (Part A and Part B) to evaluate the responsiveness of various biomarkers of immunity to Varicella-Zoster Virus (VZV) following repeated immunizations with heat treated VZV vaccine V212 or with Zostavax™.
- Trial name
- NCT00886613
- Testing
- V212, Comparator: Zostavax™, VZV Skin Test
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Non Small Cell Lung Cancer
A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
Determine whether viagenpumatucel-L combined with low-dose cyclophosphamide prolongs survival in patients with NSCLC who failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone.
- Trial name
- NCT02117024
- Testing
- Viagenpumatucel-L, Metronomic Cyclophosphamide, Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)
- Where
- 16 sites in United States
- Volunteers
- 66 people
- Sponsor
- Heat Biologics
Heat Stroke
Efficacy and Safety of Ryanodex® (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)
Study EGL-4104-C-1502 is a phase 2, single-site, open-label, randomized, 2-arm parallel study of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) administered intravenously (IV), to current standard of care…
- Trial name
- NCT02513095
- Testing
- Dantrolene sodium for injectable suspension
- Where
- Saudi Arabia
- Volunteers
- 34 people
- Sponsor
- Eagle Pharmaceuticals, Inc.
Lung Cancer, Lung Cancer Metastatic
ANET Electrosurgery Applicator Pilot Evaluation Study
Evaluate the preliminary safety and performance of the Electrosurgery Applicator (ANET device) during and after bronchoscopic ablation of a target pulmonary nodule/tumor.
- Trial name
- NCT03400748
- Testing
- RF Ablation
- Where
- 4 sites in United States, Canada
- Volunteers
- 6 people
- Sponsor
- Olympus Corporation of the Americas
Tonsillitis
PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® TnA during subcapsular tonsillectomy; to monitor and record post-operative clinical outcome variables; and to compare these…
- Trial name
- PRECISE (NCT01193556)
- Testing
- PEAK PlasmaBlade TnA, Traditional Electrosurgery with scalpel
- Where
- 2 sites in United States
- Volunteers
- 51 people
- Sponsor
- Medtronic Surgical Technologies