Clinical trials: Lower Gastrointestinal Disorder
Cystic Fibrosis
Aztreonam Lysine for Pseudomonas Infection Eradication Study
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection.
- Trial name
- ALPINE (NCT01375049)
- Testing
- Aztreonam for Inhalation Solution (AZLI)
- Where
- 58 sites in United States, Austria and 7 more
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences
Urinary Retention, Urinary Urge Incontinence
Axonics SacRal NeuromodulaTIon System RegisTRY Study
To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).
- Conditions
- Urinary Retention, Urinary Urge Incontinence, Urgency-Frequency, Fecal Incontinence
- Trial name
- ARTISTRY (NCT05064384)
- Where
- 27 sites in United States, Canada
- Volunteers
- 272 people
- Sponsor
- Axonics, Inc.
Urinary Incontinence, Fecal Incontinence
Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD)
This clinical investigation is a single-arm, prospective, multicentre, early feasibility study, which is used to evaluate the device design of UCon with respect to initial clinical safety and device performance in a small number…
- Conditions
- Urinary Incontinence, Fecal Incontinence, Urge Incontinence, Nocturia
- Trial name
- NCT05368246
- Testing
- UCon
- Where
- 3 sites in Denmark
- Volunteers
- 80 people
- Sponsor
- InnoCon Medical
Fecal Incontinence
Autologous Cell Therapy for Treatment of Fecal Incontinence
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment…
- Trial name
- NCT01600755
- Testing
- Iltamiocel
- Where
- 2 sites in Canada, United Kingdom
- Volunteers
- 53 people
- Sponsor
- Cook MyoSite
Esophageal Cancer, Gastric Cancer
A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors
This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M17D1 in…
- Conditions
- Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Colorectal Cancer
- Trial name
- NCT06500052
- Testing
- BL-M17D1
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Reflux Episodes
14473 - D9126C00001 Proof of Principle Study - Effect of AZD2066 on Transient Lower Esophageal Sphincter Relaxations
The purpose of the study is to assess the safety and tolerability of AZD2066 and to explore the effect of a single dose of AZD2066 on the function of the cardia (the opening between the stomach and the esophagus) compared to…
- Trial name
- NCT00813306
- Testing
- AZD2066
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
Aquarius Pilot Study to Evaluate the New Axonics Trial System
Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
- Conditions
- Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Fecal Incontinence (FI), Overactive Bladder (OAB)
- Trial name
- NCT07335484
- Testing
- Axonics External Trial System (ETS)
- Where
- 5 sites in United States, Australia
- Volunteers
- 75 people
- Sponsor
- Axonics, Inc.
Infectious Diseases, Healthy Subjects
Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
This single-center, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of…
- Conditions
- Infectious Diseases, Healthy Subjects, Respiratory Tract Infections, Sore Throat
- Trial name
- NCT01033799
- Testing
- Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®), Non fermented dairy product (control)
- Where
- Germany
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Danone Global Research & Innovation Center
GastroIntestinal Bleeding
Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment
In patients who show signs of bleeding and bleeding after polypectomy such as EMR and ESD for polyps with a diameter of 2 cm or more in the lower gastrointestinal tract, the effectiveness and safety of Nexpowder as an endoscopic…
- Trial name
- NCT05884931
- Testing
- Nexpowder, Conventional Treatment
- Where
- 3 sites in South Korea
- Volunteers
- 66 people
- Sponsor
- Next Biomedical Co., Ltd.
Gastroesophageal Reflux Disease
Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease
The EndoStim Stimulation System is an investigational device intended to improve the lower esophageal sphincter (LES) resting tone and restore LES function in individuals suffering with gastroesophageal reflux disease (GERD).
- Trial name
- NCT01578642
- Testing
- EndoStim LES Stimulation System
- Where
- Chile
- Volunteers
- 24 people
- Sponsor
- EndoStim Inc.
Cystic Fibrosis, Pseudomonas Aeruginosa
Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways
This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation…
- Trial name
- PALS (NCT01404234)
- Testing
- AZLI
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 61 people
- Sponsor
- Gilead Sciences
Gastroesophageal Reflux
RETHINK REFLUX Registry
The RETHINK REFLUX Registry is a post-market prospective, multi-center, observation, single arm, long-term safety surveillance registry of subjects implanted with the LINX device.
- Trial name
- NCT04253392
- Testing
- LINX Reflux Management System
- Where
- 28 sites in United States, Austria and 4 more
- Volunteers
- 500 people
- Sponsor
- Ethicon Endo-Surgery
Acute Graft-Versus-Host Disease, GIGVHD
A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease
The objectives of this trial were to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in participants with acute graft-versus-host disease (GVHD) of the lower…
- Trial name
- GIGVHD (NCT02245412)
- Testing
- ALXN1007 10 mg/kg once weekly, ALXN1007 20 mg/kg once weekly, ALXN1007 20 mg/kg twice weekly
- Where
- 12 sites in United States, France
- Volunteers
- 25 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Gastric Cancer
First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma
This is a phase 3, multicenter, randomized, double-blind, placebo controlled study of epirubicin, cisplatin \& capecitabine (ECX) with rilotumumab or placebo for untreated advanced MET-positive gastric or gastroesophageal…
- Trial name
- RILOMET-1 (NCT01697072)
- Testing
- Rilotumumab, Epirubicin, Cisplatin
- Where
- 189 sites in United States, Australia and 25 more
- Volunteers
- 609 people
- Sponsor
- Amgen
Gastroesophageal Reflux Disease (GERD), Reflux, Gastroesophageal
An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux
The purpose of this investigation is to demonstrate the safety and effectiveness of Lower Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease (GERD).
- Conditions
- Gastroesophageal Reflux Disease (GERD), Reflux, Gastroesophageal, Gastroesophageal Reflux, Acid Reflux
- Trial name
- NCT02749071
- Testing
- Laparoscopic implantation surgery with or without crural repair, EndoStim stimulation for first six months of study, EndoStim stimulation from Month 6 thru end of study
- Where
- 21 sites in United States, Belgium and 2 more
- Volunteers
- 161 people
- Sponsor
- EndoStim Inc.
Overweight, Fatty Liver Disease
The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults
To assess whether orange peel fermentation has the effect of reducing body fat in adults
- Trial name
- NCT04496895
- Testing
- orange peel fermentation
- Where
- Taiwan
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- TCI Co., Ltd.
Incontinence, Urinary, Incontinence, Fecal
Testing the Protective and Caring Effect of a Water-in-oil Formulation in Patients Suffering From Urinary and/or Fecal Incontinence and Requiring Incontinence Care Products
The aim of this study is to test the protecting and caring effect of a protective balm on patients suffering from urinary and/or fecal incontinence and need incontinence care products.
- Trial name
- NCT06924502
- Testing
- Protective Balm
- Where
- Germany
- Volunteers
- 33 people
- Sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
Gastrointestinal Diseases
Exploratory Study of Upper and Lower Endoscopic Fuse System
Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology
- Trial name
- NCT02651857
- Testing
- Fuse® Colonoscope, Fuse® Gastroscope
- Volunteers
- 1,000 people
- Sponsor
- EndoChoice Inc.
Urinary Incontinence, Urinary Incontinence, Urge
Safety and Performance of UCon Patch Electrode
UCon is a medical device for treating the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behavior of the bladder/bowel musculature e.g.…
- Conditions
- Urinary Incontinence, Urinary Incontinence, Urge, Nocturia, Urinary Frequency More Than Once at Night
- Trial name
- NCT06754189
- Testing
- Time Limited stimulation
- Where
- 3 sites in Denmark
- Volunteers
- 180 people
- Sponsor
- InnoCon Medical
Cystic Fibrosis
Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis
This study assessed time to recurrence of infection with Pseudomonas aeruginosa following treatment of the initial infection with tobramycin nebuliser solution.
- Trial name
- ELITE (NCT00391976)
- Testing
- Tobramycin solution for inhalation 300 mg
- Volunteers
- 123 people
- Sponsor
- Novartis