Clinical trials: Gastro Intestinal Surgery
Colon Neoplasms, Crohn Disease (CD)
Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery
This is a first-in-human feasibility study designed to evaluate the safety and performance of the SEGER device in patients undergoing elective laparoscopic gastrointestinal surgery requiring intracorporeal anastomosis.
- Conditions
- Colon Neoplasms, Crohn Disease (CD), Obesity & Overweight
- Trial name
- SEGER-FIH (NCT07508592)
- Testing
- SEGER Device
- Where
- El Salvador
- Volunteers
- 10 people
- Sponsor
- Seger Surgical Solutions
Cholangiopancreatography, Endoscopic Retrograde
A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
The objective of the SAMISEN study phase B is to assess the performance and safety of diagnostic and therapeutic procedures with the Olympus Motorized Spiral Enteroscope (PowerSpiral) in subjects with surgically altered…
- Trial name
- SAMISEN-B (NCT05129449)
- Testing
- Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
- Where
- 5 sites in Belgium, Germany and 1 more
- Volunteers
- 89 people
- Sponsor
- Olympus Europe SE & Co. KG
Pathologic Stage I Gastric Cancer AJCC v8, Colorectal Cancer
Clinical Trial to Evaluate the Efficacy and Safety of a Thoracic and Abdominal Endoscopic Surgical System
Evaluation of the efficacy and safety of thoracic and abdominal endoscopic surgical systems manufactured by Shenzhen Cornerstone Robotics Technology Co., Ltd. for use in general, gynaecological and thoracic surgical procedures.
- Conditions
- Pathologic Stage I Gastric Cancer AJCC v8, Colorectal Cancer, Esophageal Cancer, Hepatectomy
- Trial name
- NCT06587152
- Testing
- Robot-assisted surgery
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Cornerstone Robotics
Gastrointestinal Anastomosis
Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery
The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or…
- Trial name
- NCT02109991
- Testing
- CG-100 device
- Where
- 8 sites in Belgium, Croatia and 2 more
- Volunteers
- 60 people
- Sponsor
- Colospan Ltd.
Gastrointestinal Cancer
Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran® 2 Usability Trial in EMR and ESD
The aim of this single-center study is to evaluate the feasibility of the technique, usability and safety of the device ENDONEB.
- Trial name
- NCT06588881
- Testing
- nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection
- Where
- Italy
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GEM SRL
Stomach Neoplasms, Rectal Neoplasms
Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing a Treatment Plan of Preoperative Chemotherapy and Radiation Therapy, Followed by Surgery
The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa on the reduction in red blood cell transfusions needed in gastric cancer patients and rectal cancer patients undergoing a treatment plan of…
- Trial name
- NCT00036400
- Testing
- epoetin alfa
- Volunteers
- 60 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ileus, Post-Operative Adhesions
A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection
The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel…
- Trial name
- PROFILE (NCT02836470)
- Testing
- LB1148
- Where
- 28 sites in United States
- Volunteers
- 112 people
- Sponsor
- Palisade Bio
Hypoglycemia, Complications of Bariatric Procedures
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
The primary objective of this study is to test an optimized control system for sensor-guided (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical setting in patients with severe…
- Trial name
- NCT02733588
- Testing
- G-Pump™ (glucagon infusion)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Xeris Pharmaceuticals
Barrett's Esophagus, Esophageal Cancer
Study of CryoSpray Ablation(TM)to Determine Treatment Effect, Depth of Injury, and Side Effects in the Esophagus.
The purpose of this study is to evaluate the treatment effect, depth of injury, and side effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") onto…
- Trial name
- ESODOI (NCT00754468)
- Testing
- Cryo Spray Ablation
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- CSA Medical, Inc.
Colorectal Cancer
Vaccine Therapy in Treating Patients With Stage II or Stage III Colon Cancer That Has Been Removed During Surgery
RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells.
- Trial name
- NCT00016133
- Testing
- BCG vaccine, autologous tumor cell vaccine, fluorouracil
- Where
- 2 sites in United States
- Sponsor
- Intracel
Rectal Neoplasms
A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.
The purpose of this study is to help answer the following research questions: If the study drug Pemetrexed can help patients with rectal cancer; If molecular biological parameters are correlated respectively changing due to…
- Trial name
- NCT00330915
- Testing
- pemetrexed
- Where
- Sweden
- Volunteers
- 37 people
- Sponsor
- Eli Lilly and Company
Colorectal Surgery, Colorectal Cancer
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an…
- Conditions
- Colorectal Surgery, Colorectal Cancer, Rectal/Anal, Ileostomy - Stoma
- Trial name
- COLO-BT (NCT05826743)
- Testing
- COLO BT™, Stoma Creation
- Where
- 3 sites in United States
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- JSR Medical Co., Ltd.
Elective Surgical Procedures, Digestive System
Seal-G Safety Study
The purpose of this study is to farther assess the safety of the Seal-G Surgical Sealant for the reinforcement and protection of gastrointestinal anastomosis.
- Trial name
- NCT02825173
- Testing
- Seal-G
- Where
- 3 sites in Israel, Italy
- Volunteers
- 20 people
- Sponsor
- Sealantis Ltd.
Fecal Incontinence
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
- Trial name
- TRANSFORM (NCT01090739)
- Testing
- TOPAS Treatment for Fecal Incontinence
- Where
- 14 sites in United States
- Volunteers
- 207 people
- Sponsor
- ASTORA Women's Health
Colorectal Cancer
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)
This is a controlled study designed to compare relapse-free survival and overall survival in patients receiving UFT with those in patients receiving surgery alone.
- Trial name
- NCT00152230
- Testing
- UFT (uracil, tegafur), Surgery alone
- Where
- Japan
- Volunteers
- 900 people
- Sponsor
- Taiho Pharmaceutical Co., Ltd.
Colorectal Cancer
A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer.
- Trial name
- NCT00009737
- Testing
- 5-Fluorouracil, Leucovorin, Capecitabine [Xeloda]
- Where
- 133 sites in United States, Argentina and 12 more
- Volunteers
- 1,987 people
- Sponsor
- Hoffmann-La Roche
Gastric Cancer
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)
This is a controlled study designed to evaluate the efficacy of UFT on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by UFT within 6 weeks after…
- Trial name
- NCT00152243
- Testing
- UFT (uracil, tegafur), Surgery alone
- Where
- Japan
- Volunteers
- 500 people
- Sponsor
- Taiho Pharmaceutical Co., Ltd.
Colorectal Cancer
A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.
This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o.
- Trial name
- NCT00502671
- Testing
- capecitabine [Xeloda]
- Where
- 46 sites in Russia
- Volunteers
- 228 people
- Sponsor
- Hoffmann-La Roche
Colon Neoplasms
AI-Assisted Microbiome Analysis for Evaluating the Efficacy of MPRO3 and Gut Environmental Changes in Colon Cancer Surgery Patients
The goal of this clinical trial is to evaluate the effects of MPRO3(probiotics mixture) supplementation on surgical outcomes and gut health in patients undergoing surgery for colon cancer.The main question is whether MPRO3…
- Trial name
- AI-MPRO3 (NCT07792980)
- Testing
- MPRO3
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- hy Co., LTD.
Protein Losing Enteropathy
Pilot/Ph I Safety and Efficacy of ODSH in Protein Losing Enteropathy Secondary to Single Ventricle Palliative Surgery
Protein Losing Enteropathy (PLE) is a serious medical condition that may develop in children and adults with congenital heart disease for which a palliative procedure known as the "Fontan procedure" has been performed.
- Trial name
- NCT01161641
- Testing
- ODSH at 0.125 mg/kg/h, ODSH at 0.375 mg/kg/h, ODSH at 0.250 mg/kg/h
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- Jazz Pharmaceuticals