Clinical trials: Birth Injuries
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.
Bronchopulmonary Dysplasia
Safety and Efficacy Evaluation of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia
PNEUMOSTEM® is human umbilical cord blood derived mesenchymal stem cells and it is intended to treat premature infants with bronchopulmonary dysplasia. This study is to assess the safety and the efficacy of this study drug.
- Trial name
- NCT01297205
- Testing
- Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- Medipost Co Ltd.
Infectious Disease, Neoplasms
AnovaOS Network Powered Patient Registry
The objective of this study is the development, implementation and management of a registry of patient data that captures clinically meaningful, real-world, data on the diagnosis, nature, course of infection, treatment(s) and…
- Conditions
- Infectious Disease, Neoplasms, Diseases of the Blood and Blood-Forming Organs and Certain Disorders Involving the Immune Mechanism (D50-D89), Endocrine, Nutritional and Metabolic Diseases (E00-E89)
- Trial name
- NCT05013944
- Where
- United States
- Volunteers
- 100,000 people, healthy volunteers welcome
- Sponsor
- Anova Enterprises, Inc
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.
Cerebral Palsy, Multiple Sclerosis
Measuring Signatures in the Fluid Surrounding the Spinal Cord in Patients Who Have Problems With Intrathecal Drug Delivery
The purpose of this study is to record signatures from the fluid surrounding the spinal cord from people who have an implanted drug infusion system.
- Conditions
- Cerebral Palsy, Multiple Sclerosis, Traumatic Brain Injury, Spinal Cord Injury
- Trial name
- NCT01117090
- Where
- 2 sites in United States
- Volunteers
- 47 people
- Sponsor
- MedtronicNeuro
Needle Stick
Simulated Clinical Use Testing on Safe'N'Sound 1ML Stalked Passive Delivery System With Add-On Extended Finger Flanges
A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with add-on extended finger flanges
- Trial name
- NCT02663635
- Testing
- Safe'N'Sound
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nemera La Verpilliere
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- Sponsor
- Bayer
Acute Kidney Injury, Acute Renal Failure
Post-Market Observation Study of Intra-renal Drug Delivery (PROVIDE)
This is a prospective, observational, multi-center study with consecutive enrollment. Up to 500 patients will be enrolled. All (consecutive) adult patients in whom one or more components of the Benephit Infusion System are…
- Conditions
- Acute Kidney Injury, Acute Renal Failure, Renal Failure Chronic Contrast Induced, Chronic Kidney Disease
- Trial name
- PROVIDE (NCT01064895)
- Testing
- Benephit catheter for Targeted Renal Therapy
- Where
- 15 sites in United States
- Sponsor
- Angiodynamics, Inc.
Bronchopulmonary Dysplasia
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5…
- Trial name
- NCT00931632
- Testing
- Inhaled Nitric Oxide
- Where
- 33 sites in United States, Canada
- Volunteers
- 451 people
- Sponsor
- Mallinckrodt
Bronchopulmonary Dysplasia, Respiratory Tract Infections
Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study
This is a 5-year long-term follow-up study of open label, single-center, phase I clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with bronchopulmonary dysplasia.
- Conditions
- Bronchopulmonary Dysplasia, Respiratory Tract Infections, Premature Birth of Newborn
- Trial name
- NCT02023788
- Testing
- PNEUMOSTEM
- Where
- South Korea
- Volunteers
- 8 people
- Sponsor
- Medipost Co Ltd.
Bronchopulmonary Dysplasia
A Clinical Safety Study of AT-100 (rhSP-D) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia (BPD)
The purpose of this study is to determine if an investigational drug, AT-100, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in babies born premature, as compared to babies born premature who receive an air-sham…
- Trial name
- NCT04662151
- Testing
- AT-100
- Where
- 19 sites in United States, Spain
- Volunteers
- 37 people
- Sponsor
- Airway Therapeutics, Inc.
Childbirth
A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth
This feasibility study is a prospective, non-randomized, single arm study to evaluate safety and prevention of maternal pelvic soft-tissue damage using the Materna Medical Device.
- Trial name
- NCT06698185
- Testing
- Materna Prep Device
- Where
- United States
- Sponsor
- Materna Medical
Iliac Artery Occlusive Disease
A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
To determine the safety and effectiveness of the LUMINEXX stent for the proposed indication of treatment of common and/or external iliac artery occlusive disease
- Trial name
- Luminexx (NCT00561457)
- Testing
- Bard Luminexx Iliac Stent and Delivery System
- Volunteers
- 134 people
- Sponsor
- C. R. Bard
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
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
Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia
Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)
Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and infection.
- Trial name
- NCT01473264
- Testing
- recombinant human CC10 (rhCC10)
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Clarassance, 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.
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.
Vaginal Delivery, Pelvic Organ Prolapse
EASE: The Materna Prep Pivotal Study
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
- NCT03973281
- Testing
- Materna Prep Device, Standard of Care (SOC)
- Where
- 22 sites in United States
- Volunteers
- 420 people
- Sponsor
- Materna Medical
Anorectal Surgeries
Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Colon Surgery
EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).
- Trial name
- NCT02617706
- Testing
- Epiflo
- Where
- United States
- Sponsor
- Neogenix, LLC dba Ogenix