Clinical trials: Diaphragmatic Hernia
Congenital Diaphragmatic Hernias
Contribution of PRF in CDH in Children With Prothetic Patch Closure
Improved management of giant congenital diaphragmatic hernias (CDH) in neonates : decreased risk of morbidity and mortality due to prosthesis release.
- Trial name
- HECODIAP (NCT03861182)
- Testing
- Biological functionalization of the prosthetic materials by PRF
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University Hospital, Strasbourg, France
Paraesophageal Hernia
Short Esophagus in Type II-IV Hiatus Hernia
Background: The existence, diagnosis and treatment of short esophagus is one of the controversies of the past which has recently re-emerged.
- Trial name
- SEHH (NCT01587859)
- Testing
- laparoscopic surgery
- Where
- 2 sites in Italy
- Volunteers
- 34 people
- Sponsor
- University of Bologna
Rare Diseases, Congenital Diaphragmatic Hernia
Intact Cord Resuscitation in CDH
Isolated CDH is a rare disease (1/3500) and displays a wide range of severity and outcome. Despite attempts to standardize the management of this disease at birth and during the first months of life, the mortality varies from 20…
- Trial name
- CHIC (NCT04429750)
- Testing
- Immediate umbilical cord clamping, intact cord resuscitation
- Where
- 3 sites in France
- Volunteers
- 180 people
- Sponsor
- University Hospital, Lille
Hernia, Hiatal
Laparoscopic Repair of Giant Hiatal Hernias With Nitinol-framed Lightweight Polytetrafluoroethylene Mesh
This study is prospective randomized trial enrolling at least 50 participants which compares efficacy and safety of two alternative methods of laparoscopic hiatal repair for giant (i.e.
- Trial name
- GIANT (NCT01780285)
- Testing
- Nitinol-framed lightweight PTFE mesh for hiatal repair, Partially absorbable lightweight mesh for hiatal repair
- Where
- Ukraine
- Volunteers
- 50 people
- Sponsor
- Odessa National Medical University
Hiatal Hernia, Paraesophageal Hernia
Study of Paraesophageal Hernia Repair With Small Intestine Submucosa
In 2006 this research group reported their initial findings of a multi-center prospective trial comparing primary repair and primary repair buttressed with a biologic mesh made from porcine small intestinal submucosa (SIS).
- Trial name
- PEH (NCT00786084)
- Where
- 4 sites in United States
- Volunteers
- 108 people
- Sponsor
- University of Washington
Congenital Diaphragmatic Hernia
Fetal Endoscopic Tracheal Occlusion for CDH (CDH)
This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter…
- Trial name
- FETO (NCT05421676)
- Testing
- FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of California, Davis
Gastroesophageal Reflux
Manual Therapy and Gastroesophageal Reflux Disease in Patients With Hiatal Hernia
Introduction: Gastroesophageal reflux disease (GERD) is highly prevalent in our society. The association between GERD and hiatal hernia has been shown to be etiologically critical in the onset or worsening of these patients'…
- Trial name
- NCT05283447
- Testing
- Osteopathic Medicine, Control
- Where
- Spain
- Volunteers
- 44 people
- Sponsor
- Escoles Universitaries Gimbernat
Hiatal Hernia
Usage of Biological Patch Versus Plastic in the Laparoscopic Repair of Hiatal Hernias
The purpose of this study is to observe the effective and safety in the laparoscopic repair of hiatal hernia using biological patch versus plastic.
- Trial name
- NCT02328248
- Testing
- Biological patch
- Volunteers
- 150 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Congenital Diaphragmatic Hernia
Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)
Despite advances in prenatal diagnosis and postnatal therapies, including extracorporeal membrane oxygenation (ECMO), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity…
- Trial name
- FETO (NCT02710968)
- Testing
- 11540KE and Balt Goldbal 2 balloon
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Johns Hopkins University
GERD, Hiatal Hernia
Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
This single-blind randomized control study will follow 142 subjects across 7 sites randomized on a 1:1 ratio to compare treatment efficacy and safety between TIF and LNF in GERD patients with hiatal hernia undergoing hernia…
- Trial name
- CTIF (NCT04795934)
- Testing
- LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION
- Where
- 7 sites in United States
- Volunteers
- 142 people
- Sponsor
- Mayo Clinic
Congenital Diaphragmatic Hernia, Fetal Surgery
Fetal Surgery for Moderate Left Sided Congenital Diaphragmatic Hernia.
Isolated Congenital Diaphragmatic Hernia (CDH) can be diagnosed in the prenatal period, and remains associated with a 30 % chance of perinatal death and morbidity mainly because of pulmonary hypoplasia and pulmonary hypertension.
- Conditions
- Congenital Diaphragmatic Hernia, Fetal Surgery, Pulmonary Hypoplasia
- Trial name
- TOTAL moderate (NCT00763737)
- Testing
- Fetoscopic Endoluminal Tracheal Occlusion
- Where
- 13 sites in United States, Australia and 8 more
- Volunteers
- 196 people
- Sponsor
- University Hospital, Gasthuisberg
Congenital Diaphragmatic Hernia
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic.
- Trial name
- FETO (NCT05962346)
- Testing
- BALT GOLDBALL 2 detachable latex ballon, BALTACCIBDPE100 Microcatheter, Storz fetoscopic operating sheath and miniature telescope/fetoscope
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Mauro H. Schenone
Hiatal Hernia
Miromatrix Biological Mesh for Hiatal Hernia Repair
Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived from the highly vascularized porcine liver.
- Trial name
- NCT02436681
- Testing
- MIROMESH
- Where
- 6 sites in United States
- Volunteers
- 50 people
- Sponsor
- Miromatrix Medical Inc.
General Laparoscopic Surgery Candidate, Bariatric Laparoscopic Surgery Candidate
Usability and Performance Evaluation of the AutoLap System - a Feasibility Study
The main objectives of this study are to evaluate the ease of use and performance of the AutoLap system compared to human camera holder during general and bariatric laparoscopic surgeries.
- Trial name
- NCT02346552
- Testing
- AutoLap
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- M.S.T. Medical Surgery Technology LTD.
Congenital Diaphragmatic Hernia
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
The purpose of this research is to determine if babies who undergo a Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure survive more often and have less long-term complications than babies who have similarly severe…
- Trial name
- NCT07564297
- Testing
- Fetoscopic Endoluminal Tracheal Occlusion, Standard of Care
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Mayo Clinic
Hernia, Diaphragmatic, Hypertension, Pulmonary
Chronic Sildenafil for Severe Diaphragmatic Hernia
The purpose of this study is to test if sildenafil is effective in the treatment of infants with severe congenital diaphragmatic hernia (determined by the presence of prolonged pulmonary hypertension or prolonged oxygen…
- Conditions
- Hernia, Diaphragmatic, Hypertension, Pulmonary, Hypoplasia, Pulmonary
- Trial name
- NCT00133679
- Testing
- sildenafil
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- University of California, San Francisco
Hernia, Hiatal, GERD (Gastroesophageal Reflux Disease)
TLSA Versus TBSA Surgical Approach for Hiatal Hernia With Gastroesophageal Reflux Disease
Gastroesophageal reflux disease (GERD), characterized by pathological reflux of gastric contents, affects 10%-20% of the global population with Western predominance and escalating incidence over recent decades.
- Trial name
- NCT07252115
- Testing
- Laparoscopic total left-sided surgical approach, Laparoscopic traditional bilateral approach
- Where
- 2 sites in China
- Volunteers
- 143 people
- Sponsor
- Beijing Friendship Hospital
Paraesophageal Hernia
ACELL Mesh for Paraesophageal Hernia Repair
This is a prospective, case-matched, systematic follow up of up to 70 pre-existing patients whom underwent paraesophageal hernia repair between June 1, 2012 and September 30, 2016.
- Trial name
- NCT03058731
- Testing
- Matristem, Control
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- University of South Florida
Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital
Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia
Pulmonary hypertension is a major determinant of postnatal survival in infants with a congenital diaphragmatic hernia (CDH). The current care during the perinatal stabilisation period in infants born with this rare birth defect…
- Conditions
- Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Pulmonary Hypertension
- Trial name
- PinC (NCT04373902)
- Testing
- Physiological-based cord clamping
- Where
- 9 sites in Australia, Austria and 5 more
- Volunteers
- 144 people
- Sponsor
- Erasmus Medical Center
Hernia, Diaphragmatic
Early Childhood Follow-up of Congenital Diaphragmatic Hernia Survivors
The primary objective of this study is to determine the medical and neurodevelopmental outcomes of congenital diaphragmatic hernia (CDH) survivors at school-age (4-6 years) follow-up.
- Trial name
- CDH (NCT01029665)
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Duke University