Clinical trials: Fundoplication, open to volunteers
GERD (Gastroesophageal Reflux Disease)
A Blinded Randomized Clinical Study of RefluxStop™ Compared With Nissen Fundoplication in the Treatment of GERD
This study will evaluate if the RefluxStop™ device will treat your acid reflux and improve your symptoms and how it compares to the standard surgical treatment for GERD, the Nissen fundoplication.
- Trial name
- RENEW RCT (NCT07004400)
- Testing
- RefluxStop™ implantation, Nissen fundoplication
- Where
- 4 sites in Austria, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Implantica CE Reflux Ltd.
Achalasia
POEM-F for Achalasia International Study
Per-oral endoscopic myotomy (POEM) has emerged as the endoscopic treatment of choice for achalasia, offering comparable symptom relief with laparoscopic Heller's cardiomyotomy.
- Trial name
- NCT06042127
- Testing
- POEM-F, Conventional POEM
- Where
- 7 sites in United States, China and 2 more
- Volunteers
- 81 people
- Sponsor
- Chinese University of Hong Kong
Fundoplication, GERD
Transoral Incisional Fundoplication (TIF) for Patients Suffering From Gastroesophageal Reflux Disease in an Asian Population
Transoral incisionless fundoplication (TIF) has become a widely used intervention to restore the valve at the gastroesophageal junction in selected patients suffering from gastroesophageal reflux disease (GERD).
- Trial name
- NCT07556289
- Testing
- Transoral incisional fundoplication
- Where
- Hong Kong
- Volunteers
- 20 people
- Sponsor
- Chinese University of Hong Kong
Perioperative Pain Management, Gastreoesophageal Reflux Disease
Intrathecal Analgesia in Laparoscopic Nissen Fundoplication.
Patients planned for laparoscopic Nissen fundoplication or robotic- assisted laparoscopic surgery will receive either intrathecal morphine, intrathecal fentanyl or iv morphine (control).
- Trial name
- NCT07629323
- Testing
- Fentanyl Intrathecal 20ug, NOL-guided intravenous morphine analgesia, Intrathecal Morphine 100ug
- Where
- Sweden
- Volunteers
- 63 people
- Sponsor
- Karlstad Central Hospital
Hiatal Hernia Large
Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia
Patients who underwent laparoscopic repair of large hiatal hernias and anterior fundoplication with mesh are examined for their recurrence rate one year after surgery.
- Trial name
- NCT03025932
- Testing
- repair of giant hiatal hernia with mesh and anterior fundoplication
- Volunteers
- 200 people
- Sponsor
- Prof Urs Zingg
Esophageal Achalasia, Esophageal Motility Disorders
POEM Versus Laparoscopic Heller Myotomy With Dor Fundoplication for Esophageal Achalasia
Achalasia is a disorder of the esophagus in which the muscular valve between the esophagus and the stomach fails to relax, and the body of the esophagus loses its normal coordinated squeezing movement.
- Conditions
- Esophageal Achalasia, Esophageal Motility Disorders, Gastroesophageal Reflux
- Trial name
- POEM-HD (NCT07814027)
- Testing
- Peroral endoscopic myotomy, Laparoscopic Heller myotomy with Dor fundoplication
- Where
- Egypt
- Volunteers
- 220 people
- Sponsor
- Minia University
Paraesophageal Hernia
Gastropexy as a Treatment Option for Paraesophageal Hernia
The present proposal aims to asses which is the optimal treatment strategy in a clinical study in patients with paraoesophageal hernia (PEH), a condition often found in elderly, fragile patients The investigator want to study the…
- Trial name
- NCT06096402
- Testing
- no intervention, but surgical practice as usual is continued. Its a pragmatic study
- Where
- 3 sites in Denmark, Norway
- Volunteers
- 220 people
- Sponsor
- University Hospital of North Norway
Hiatal Hernia With Gastroesophageal Reflux Disease
Comparison of Laparoscopic Nissen Fundoplication and Hill-Snow Repair for Hiatus Hernia With Endoscopic Evaluation
The goal of this clinical trial is to compare the clinical efficacy and safety of laparoscopic Nissen fundoplication (LNF) versus laparoscopic Hill-Snow repair (LHS) in the management of patients with congenital hiatus hernia, to…
- Trial name
- NCT07387042
- Testing
- Laparoscopic Hill-Snow repair, Laparoscopic Nissen Fundoplication
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Minia University
Gastro-oesophageal Reflux Disease
LINX vs Fundoplication
Reflux disease can severely impact upon quality-of-life and lead to complications, including ulceration of the oesophagus. It is often controlled with self-help measures and medication. However, sometimes surgery is recommended.
- Trial name
- GOLF (NCT07093359)
- Testing
- Laparoscopic or robotic LINX procedure, Laparoscopic or robotic fundoplication
- Where
- 5 sites in United Kingdom
- Volunteers
- 460 people
- Sponsor
- University of Oxford
Indications for Laparoscopic Thoracic and Abdominal Surgery in Children, Congenital or Acquired Surgical Conditions Requiring Minimally Invasive Surgery in Children
Clinical Trial on Safety and Efficacy of Thoracoabdominal Endoscopic Surgical System for Pediatric Surgery
This is a prospective, multi-center, single-arm, target-value clinical trial conducted to evaluate the safety and effectiveness of the Thoracic and Abdominal Endoscopic Surgery System (model WJ-SR01-200) in pediatric surgical…
- Conditions
- Indications for Laparoscopic Thoracic and Abdominal Surgery in Children, Congenital or Acquired Surgical Conditions Requiring Minimally Invasive Surgery in Children, Pyeloplasty, Ureteral Reimplantation
- Trial name
- NCT07530133
- Testing
- Thoracic and Abdominal Endoscopic Surgery System
- Where
- 3 sites in China
- Volunteers
- 64 people
- Sponsor
- Hangzhou Kangji Weijing Medical Robotics Co., Ltd.
Gastro -Oesophagal Reflux, Laryngo-pharyngeal Reflux
European TIF2.0 Registry
This is a European, multi-centre, prospective registry that aims to determine the safety and efficacy of transoral incisionless fundoplication, with or without concomitant hiatal hernia repair, for the treatment of patients with…
- Trial name
- EURO-TIF (NCT07395219)
- Testing
- Transoral incisionless fundoplication with or without concomitant hiatal hernia repair with the EsophyX device
- Where
- 7 sites in Austria, Italy and 5 more
- Volunteers
- 500 people
- Sponsor
- Cleveland Clinic London
Hiatal Hernia, Paraesophageal, Hiatal Hernia Large
Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.
This randomized controlled trial compares laparoscopic Nissen fundoplication and laparoscopic Toupet fundoplication in patients undergoing surgical treatment for hiatal hernia associated with gastroesophageal reflux disease.
- Conditions
- Hiatal Hernia, Paraesophageal, Hiatal Hernia Large, Hiatal Hernia With Gastroesophageal Reflux Disease
- Trial name
- NCT07718828
- Testing
- Laparoscopic Nissen Fundoplication, Laparoscopic Toupet Fundoplication
- Where
- Bulgaria
- Volunteers
- 200 people
- Sponsor
- Sofia Med Hospital
Bypass, Gastric
Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass
The purpose of this study is to evaluate the efficacy of fundoplication with stomach excluded in the suppression of disabling gastroesophageal reflux requiring surgery in patients who have undergone one anastomosis gastric…
- Trial name
- FEE-RGOIC (NCT06621979)
- Testing
- Bypass surgery type one anastomosis gastric bypass
- Where
- France
- Volunteers
- 17 people
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Reflux Disease, Gastro-Esophageal
POLAR-STUDY: Polish AntiReflux Study
The goal of this observational study is to evaluate the current practice and outcomes of surgical treatment for gastroesophageal reflux disease (GERD) in adults undergoing antireflux surgery in Poland.
- Trial name
- POLAR (NCT07711912)
- Testing
- Prospective Clinical Observation and Follow-up
- Where
- Poland
- Volunteers
- 200 people
- Sponsor
- University of Warmia and Mazury in Olsztyn
Gastroesophageal Reflux Disease, Hiatal Hernia
Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication
Laparoscopic fundoplication is the standard operation for gastroesophageal reflux disease (GERD) that does not respond adequately to medication, and it relieves reflux symptoms in most patients who are carefully selected for it.
- Conditions
- Gastroesophageal Reflux Disease, Hiatal Hernia, Esophagitis, Peptic, Barrett Esophagus
- Trial name
- NCT07809620
- Testing
- Laparoscopic Nissen fundoplication, Laparoscopic Toupet fundoplication
- Where
- Egypt
- Volunteers
- 470 people
- Sponsor
- Minia University
Hiatal Hernia, Paraesophageal Hernia
Nissen Versus Dor Hiatal Hernia Repair
Hiatal hernia can present with a wide range of symptoms. An usual surgical repair technique usually includes Nissen fundoplication, while other procedures are less frequently employed.
- Conditions
- Hiatal Hernia, Paraesophageal Hernia, Recurrence
- Trial name
- NiDor (NCT06725433)
- Testing
- Nissen fundoplication, Dor fundoplication
- Where
- Finland
- Volunteers
- 150 people
- Sponsor
- Kuopio University Hospital
Gastroesophageal Reflux, Esophageal Motility Disorders
High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux
This is a combined retro- and prospective, monocentric study. All patients who underwent or are planned for laparoscopic partial fundoplication (180° anterior or 270° posterior) between 2020-2023 are assessed for preoperative…
- Conditions
- Gastroesophageal Reflux, Esophageal Motility Disorders, Upper Gastrointestinal Disorder
- Trial name
- NCT05132816
- Testing
- high-resolution manometry
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Prof Urs Zingg
GERD, Hiatal Hernia
Antireflux Surgery Without Preoperative Esophageal Manometry
The goal of this clinical trial is to learn if people can safely skip a test called esophageal manometry before surgery for acid reflux (gastroesophageal reflux disease, or GERD) or a hiatal hernia.
- Conditions
- GERD, Hiatal Hernia, Heartburn, Paraesophageal Hernia
- Trial name
- NOMA (NCT07659080)
- Testing
- Preoperative workup without high-resolution esophageal manometry, Standard preoperative workup with high-resolution esophageal manometry
- Where
- 2 sites in United States, Canada
- Volunteers
- 96 people
- Sponsor
- McMaster University
Barrett Esophagus, Transoral Incisionless Fundoplication
Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus
Barrett's esophagus (BE) is a precancerous lesion characterized by the replacement of the normal stratified squamous epithelium of the distal esophagus by intestinal metaplasia (IM).
- Trial name
- NCT04457193
- Testing
- TIF
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Johns Hopkins University
Gastro Esophageal Reflux
Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)
This observational registry aims to: 1) record the TIF interventions in patients with esophageal or extra-esophageal symptoms; 2) to monitor the therapy response through the clinical experience in terms of effect on the use and…
- Trial name
- TIF/2021 (NCT05066594)
- Testing
- Transoral incisionless fundoplication
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS San Raffaele