Clinical trials: Gastrointestinal Surgery
Hepatocarcinoma, Hepatic Metastasis
Robotic Endomicroscopy to Better Define Resection Strategies Applied to Hepatic Surgery
This study aims at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during laparoscopic hepatic masses resection for intra-operative characterisation of hepatic masses and surgical margins assessment.
- Conditions
- Hepatocarcinoma, Hepatic Metastasis, Hepatic Tumor
- Trial name
- PERSEE (NCT03718078)
- Testing
- Confocal Laser Endomicroscopy
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Mauna Kea Technologies
Gastroesophageal Reflux Disease, Hiatal Hernia
Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)
The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.
- Trial name
- NCT01118585
- Testing
- TIF Procedure
- Where
- 14 sites in United States
- Volunteers
- 278 people
- Sponsor
- EndoGastric Solutions
Esophageal Cancer, Esophagus Cancer
Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
A prospective, multi-centre, exploratory and observational one-arm study to evaluate preventive Endoluminal Vacuum Therapy(pEVT) to prevent anastomotic leakage after esophagectomy due to esophageal cancer.
- Conditions
- Esophageal Cancer, Esophagus Cancer, Anastomotic Leak
- Trial name
- ESPY (NCT06097078)
- Testing
- Eso-SPONGE®
- Where
- Spain
- Volunteers
- 44 people
- Sponsor
- Aesculap AG
Lower Abdominal Surgery, Pelvic Surgery
Objective to Evaluate the Safety and Effectiveness of LED Light Source System for Endoscopy in Ureteral Radiography
This clinical trial is a prospective, multi-center, single-blind, parallel, randomized controlled superiority clinical trial. The trial will be carried out in 5 centers, involving 120 subjects as estimated who will be divided…
- Trial name
- IRIS (NCT04561414)
- Testing
- LED light source system for endoscope, Ureteral stent (Cook Ireland Ltd.)
- Where
- 4 sites in China
- Sponsor
- Stryker Orthopaedics
Mitral Valve Regurgitation
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-I (NCT02276547)
- Testing
- Mitral valve replacement
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 27 people
- Sponsor
- Shockwave Medical, Inc.
Gastric Cancer
A Study of Capecitabine (Xeloda) in Combination Chemotherapy Versus Surgery Alone in Participants With Gastric Cancer
This study will compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation alone in chemotherapy-naive participants who have undergone potentially curative resection for gastric cancer.
- Trial name
- NCT02560974
- Testing
- Capecitabine, Oxaliplatin
- Where
- 36 sites in China, South Korea and 1 more
- Volunteers
- 1,035 people
- Sponsor
- Hoffmann-La Roche
Pancreas Cancer, Pancreas Cancer, Duct Cell Adenocarcinoma
A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC
To explore safety and efficacy of neoantigen personalized mRNA vaccines AK154 monotherapy or in combination with AK104/AK112 and sequential mFOLFIRINOX regime in Resected PDAC
- Trial name
- NCT06913218
- Testing
- AK154, Cadonilimab, Ivonescimab (SMT112 or AK112) Injection
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Akeso
Hepatocellular Carcinoma, Liver Metastases
Safety, Tolerability, PK, Anti-Tumor Activity of STP705 in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy
This is an open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of STP705 administered intratumorally in cholangiocarcinoma, hepatocellular carcinoma…
- Conditions
- Hepatocellular Carcinoma, Liver Metastases, Cholangiocarcinoma
- Trial name
- NCT04676633
- Testing
- STP705
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- Sirnaomics
Gall Bladder Disease, Bile Duct Diseases
AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study
This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips.
- Conditions
- Gall Bladder Disease, Bile Duct Diseases, Acute Cholecystitis, Kidney
- Trial name
- AE05ML (NCT06364865)
- Testing
- laparoscopic procedure
- Where
- 3 sites in United States
- Volunteers
- 161 people
- Sponsor
- Teleflex
Esophageal Cancer, Gastric Cancer
Nitrocamptothecin in Treating Patients With Locally Advanced or Metastatic Stomach Cancer That Cannot Be Removed During Surgery
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have locally…
- Trial name
- NCT00005876
- Testing
- rubitecan
- Where
- United States
- Sponsor
- Astex Pharmaceuticals, Inc.
Postoperative Ileus
Study of Dexamethasone-Allantoin-Metronidazole (DAM) Solution in the Treatment of Post-Operative Ileus (POI)
This study is being conducted to determine whether Dexamethasone-Allantoin-Metronidazole (DAM) Solution can accelerate recovery of gastrointestinal function following abdominal operation when compared with a placebo.
- Trial name
- NCT01863407
- Testing
- DAM, Normal Saline
- Where
- China
- Volunteers
- 480 people
- Sponsor
- Beijing Bozhiyin T&S Co., Ltd.
Pancreatic Neoplasm
A Study On An Immunostimulant Antibody In Combination With Chemotherapy For Advanced Cancer Of The Pancreas
This study aims to seek evidence that activation of certain cells of the immune system will be safe and well tolerated in combination with cytotoxic chemotherapy.
- Trial name
- NCT00711191
- Testing
- monoclonal antibody, chemotherapy
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Hoffmann-La Roche
Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures
A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices
This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (general, gynecological, urological, and…
- Conditions
- Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures, Adult Lower Gastrointestinal Procedures, Adult Gastric Procedures
- Trial name
- NCT05039021
- Testing
- HARMONIC 1100 Shears
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 265 people
- Sponsor
- Ethicon Endo-Surgery
Hemorrhoids
Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids
The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.
- Trial name
- HEMOSTASIS (NCT01306877)
- Testing
- EEA Hemorrhoid and Prolapse Stapling Set, Endosurgery Proximate PPH03 Stapling Set
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- Medtronic - MITG
Appendicitis, Cholecystitis
NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy
The aim of this study is to evaluate if the application of a Chlorhexidine coated suture (Novosyn® CHD) will reduce the colonization of bacteria in comparison to an uncoated suture (Novosyn®) used for the closure of trocar wounds…
- Trial name
- NOVOTILAC (NCT04033211)
- Testing
- Novosyn® CHD for fascia and skin closure, Novosyn® for fascia and skin closure
- Where
- 4 sites in Germany, Spain
- Volunteers
- 316 people
- Sponsor
- Aesculap AG
Intraoperative Bleeding, Hemorrhage, Surgical
GATT-Patch Versus TachoSil in Liver Surgery
This is a pre-market, prospective, randomized (2:1), multicenter, multi-national pivotal clinical investigation. The purpose of this investigation is to determine the clinical safety and performance of GATT-Patch as compared with…
- Conditions
- Intraoperative Bleeding, Hemorrhage, Surgical, Liver Diseases
- Trial name
- NCT05385952
- Testing
- GATT-Patch (currently named ETHIZIA), TachoSil
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 132 people
- Sponsor
- GATT Technologies BV
Hepatocellular Carcinoma
Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.
The primary objective of this study was to evaluate the efficacy of anlotinib hydrochloride capsules combined with penpulimab injection (test group) versus placebo (control group) for adjuvant therapy after radical surgery or…
- Trial name
- NCT05862337
- Testing
- Anlotinib hydrochloride capsules, Penpulimab injection
- Where
- 67 sites in China
- Volunteers
- 480 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Pancreatic Insufficiency
Creon After Pancreatic Surgery
This study will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term safety data. During the long-term treatment with Creon 25000 nutritional parameters will be assessed and correlated with CFA
- Trial name
- NCT00535756
- Testing
- Creon
- Where
- 15 sites in Bulgaria, Germany and 2 more
- Volunteers
- 58 people
- Sponsor
- Abbott Products
GERD
Registry Study of the NDO Surgical Plicator for the Treatment of GERD
The purpose of this study is to collect post-marketing data on patient outcomes and satisfaction following treatment with the Plicator™.
- Trial name
- NCT00597792
- Testing
- NDO Full-thickness Plicator
- Where
- 7 sites in United States
- Volunteers
- 131 people
- Sponsor
- NDO Surgical, Inc.
Colonic Neoplasms, Colorectal Neoplasms
Study of an Individualized Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer
The primary objective is to assess and characterize the antitumor activity and safety and tolerability of adjuvant treatment with an individualized neoantigen vaccine called GRT-C901/GRT-R902 (chimpanzee adenovirus [ChAd] and…
- Trial name
- NCT05456165
- Testing
- GRT-C901, GRT-R902, Atezolizumab
- Where
- 3 sites in United States
- Sponsor
- Gritstone bio, Inc.