Clinical trials: Delivery; Injury
Spinal Cord Injury Cervical, Spinal Cord Injury Thoracic
A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord Injury
The DOSED clinical study evaluates the safety and utility of a novel delivery device to deliver LCTOPC1, a cell therapy, to the spinal cord of patients with a spinal cord injury (SCI).
- Conditions
- Spinal Cord Injury Cervical, Spinal Cord Injury Thoracic, Spinal Cord Injury, Acute, Spinal Cord Injury
- Trial name
- DOSED (NCT06841770)
- Testing
- OPC1
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Lineage Cell Therapeutics, Inc.
Hypoxic-Ischemic Encephalopathy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant…
- Trial name
- STAR (NCT05778188)
- Testing
- RLS-0071
- Where
- 15 sites in United States
- Volunteers
- 70 people
- Sponsor
- ReAlta Life Sciences, Inc.
Obstetric Anal Sphincter Injury, Delivery Complication
Detection of Obstetric Anal Sphincter Injuries With ONIRY Device
The main purpose of the study is to confirm the clinical performance and safety of impedance spectroscopy using the ONIRY device for the detection of anal sphincter injuries arising from vaginal deliveries.
- Conditions
- Obstetric Anal Sphincter Injury, Delivery Complication, Obstetric Complication
- Trial name
- NCT04903977
- Testing
- Laboratory tests: blood and faeces tests, Gynaecological and proctological examinations, 3-D Endoanal Ultrasound
- Where
- 5 sites in Czechia, Poland and 2 more
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- OASIS Diagnostics S.A.
Vaginal Delivery, Pelvic Organ Prolapse
Materna Prep Study Phase II
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.
- Trial name
- EASE (NCT06126328)
- Testing
- Materna Prep Device
- Where
- 15 sites in United States
- Volunteers
- 214 people
- Sponsor
- Materna Medical
Bone Fracture, Fresh Fracture
Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period.
- Trial name
- NCT05883241
- Testing
- Sustained Acoustic Device with 2.5% Diclofenac Patch, 2.5% Diclofenac Patches
- Where
- 2 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- ZetrOZ, Inc.
Obstetric Anal Sphincter Injury, Delivery, Obstetric
Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries
The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in detection of anal sphincter injuries in women in the early postpartum period. The study is prospective.
- Trial name
- NCT03769792
- Testing
- Blood and faeces tests, Impedance spectroscopy test, Full gynecological and proctological examination
- Where
- Poland
- Volunteers
- 20 people
- Sponsor
- OASIS Diagnostics S.A.
Acute Kidney Failure, Chronic Kidney Diseases
Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients
To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin.
- Trial name
- NCT06358365
- Testing
- The AquaPass System
- Where
- Israel
- Volunteers
- 5 people
- Sponsor
- AquaPass Medical Ltd.
Bronchopulmonary Dysplasia
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants.
- Trial name
- NCT01897987
- Testing
- Pneumostem®, normal saline
- Where
- 2 sites in South Korea
- Volunteers
- 62 people
- Sponsor
- Medipost Co Ltd.
Blunt Thoracic Aortic Injury
Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury
The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a blunt thoracic aortic injury (BTAI).
- Trial name
- RESCUE (NCT01092767)
- Testing
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Where
- 25 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Medtronic Cardiovascular
Bronchopulmonary Dysplasia
Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants
The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing…
- Trial name
- NCT01828957
- Testing
- Pneumostem®, Normal Saline
- Where
- 2 sites in South Korea
- Volunteers
- 69 people
- Sponsor
- Medipost Co Ltd.
Critical Limb Ischemia
Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for…
- Trial name
- NCT02099500
- Testing
- Liposuction, Stem Cell Injection
- Where
- United States
- Sponsor
- Ageless Regenerative Institute
Spinal Cord Injury
Transfer of Bone Marrow Derived Stem Cells for the Treatment of Spinal Cord Injury
This study is based on preclinical (animal) studies showing that infusing bone marrow-derived mesenchymal stem cells into the spinal fluid may contribute to improving neurologic function in animal models with spinal cord…
- Trial name
- NCT01162915
- Testing
- Autologous bone marrow-derived mesenchymal stem cells.
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- TCA Cellular Therapy
Bronchopulmonary Dysplasia
Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) - a US Study
PNEUMOSTEM® consists of ex vivo cultured allogeneic, unrelated, human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) and it is intended for use as a cellular therapy product for prevention of Bronchopulmonary…
- Trial name
- NCT02381366
- Testing
- Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Medipost, Inc.
Pregnancy Related, Cesarean Wound Disruption
The Collection and Application of Autologous Amniotic Fluid At Cesarean Delivery Closure.
The purpose of this study is to determine the feasibility of collecting amniotic fluid at delivery that will be immediately processed and then applied as a spray to the various layers of cesarean wound closure.
- Conditions
- Pregnancy Related, Cesarean Wound Disruption, Cesarean Section; Infection
- Trial name
- NCT04359472
- Testing
- Application of Autologous Amniotic Fluid
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Recibio, Inc.
Neurogenic Detrusor Overactivity
Safety and Tolerability of TAR-302-5018 in Subjects With Neurogenic Detrusor Overactivity Resulting From Spinal Cord Injury
The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery system, is safe and tolerable in patients with neurogenic detrusor overactivity (NDO) resulting from spinal cord injury (SCI).
- Trial name
- NCT03168828
- Testing
- Trospium-Releasing Intravesical System (TAR-302-5018)
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- Taris Biomedical LLC
Surgical Site Infection, Thrombosis
Tumescent Anesthesia Antibiotic Delivery (TAAD)
This is a multicenter randomized clinical trial (RCT) comparing two modes of antibiotic delivery: Control: Intravenous Antibiotic Delivery (IVAD) Treatment: IVAD + TAAD The Food \& Drug Administration (FDA) has approved our…
- Conditions
- Surgical Site Infection, Thrombosis, Sepsis
- Trial name
- TAAD (NCT03226626)
- Testing
- Tumescent Anesthesia and antibiotic delivery (TAAD) plus IVAD, SubQKath
- Volunteers
- 330 people
- Sponsor
- HK Surgical, Inc.
Sepsis, Acute Kidney Injury
A Study Looking at the Use of Biomarkers to Provide Early Indication of Acute Kidney Injury in Patients With Sepsis (Limiting AKI Progression In Sepsis)
Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI.
- Conditions
- Sepsis, Acute Kidney Injury, Septic Shock
- Trial name
- LAPIS (NCT04434209)
- Testing
- Subject management guided by NephroCheck® test, Standard of Care
- Where
- 12 sites in United States, Belgium and 2 more
- Volunteers
- 19 people
- Sponsor
- BioMérieux
Pelvic Floor, Perineal Rupture
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
The mechanical demands placed on the pelvic floor structures during vaginal delivery often exceed physiological tissue limits, resulting in maternal childbirth trauma, considerable postpartum morbidity, and increased risk of…
- Conditions
- Pelvic Floor, Perineal Rupture, Obstetric Trauma
- Trial name
- NCT03883867
- Where
- 3 sites in United States, Czechia
- Volunteers
- 20 people
- Sponsor
- Advanced Tactile Imaging, Inc.
Pregnancy, Childbirth
Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up
The goal of this clinical investigation is to learn if training with Emagina device can improve flexibility of the perineum during childbirth with the help of a balloon that inflates in the genital area according to a…
- Trial name
- PeriFlex (NCT06542744)
- Testing
- Training with the Emagina device at home until birth, No intervention
- Where
- 15 sites in France
- Volunteers
- 88 people
- Sponsor
- Mumming
Chronic Spinal Cord Injury
The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury
The Up-LIFT Study is a prospective, single-arm study designed to evaluate the safety and effectiveness of non-invasive electrical spinal cord stimulation (ARC Therapy) administered by the LIFT System to treat upper extremity…
- Trial name
- Up-LIFT (NCT04697472)
- Testing
- LIFT System
- Where
- 14 sites in United States, Canada and 2 more
- Volunteers
- 65 people
- Sponsor
- ONWARD Medical, Inc.