Clinical trials: Bowel Surgery
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
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
Short Bowel Syndrome
Safety and Efficacy Study in Infant With SBS
The objective of this clinical study is to evaluate the efficacy and safety of NTRA-9620 compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks old) with SBS following surgical resection
- Trial name
- GIFT (NCT02865122)
- Testing
- NTRA-9620
- Where
- 8 sites in United States
- Volunteers
- 2 people
- Sponsor
- Elgan Pharma Ltd.
Crohn's Disease
A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence
REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in an experiment to see if it may be useful in preventing relapse of Crohn's disease after surgical resection.
- Trial name
- NCT01190839
- Testing
- Infliximab
- Where
- 142 sites in United States, Australia and 12 more
- Volunteers
- 297 people
- Sponsor
- Janssen Biotech, Inc.
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
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
Colorectal Cancer, Benign or Malignant Rectal or Colon Tumors
da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy.
- Trial name
- NCT04403022
- Testing
- Robotic Assisted Surgery
- Where
- 9 sites in United States, South Korea
- Volunteers
- 60 people
- Sponsor
- Intuitive Surgical
Rectal Cancer, Rectosigmoid Cancer
A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
This is a randomized, controlled, parallel, multicenter study to determine the difference in post-operative anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using…
- Trial name
- PILLAR III (NCT02205307)
- Testing
- PINPOINT, SPY Elite
- Where
- 24 sites in United States
- Volunteers
- 347 people
- Sponsor
- Novadaq Technologies ULC, now a part of Stryker
Colorectal Cancer
Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Purpose of the study is to assess the utility of PSD Veritas as a staple line reinforcement to minimize the risk of leakage during or after colo-rectal surgery.
- Trial name
- NCT00559013
- Testing
- Staple line reinforcement
- Where
- 2 sites in United States
- Volunteers
- 38 people
- Sponsor
- Baxter Healthcare Corporation
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
Breast Cancer, Head and Neck Squamous Cell Carcinoma
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine…
- Conditions
- Breast Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Prostate Cancer
- Trial name
- NCT03735680
- Testing
- ONM-100
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- OncoNano Medicine, Inc.
Enhanced Recovery After Surgery
Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery in Subjects Undergoing Bowel Resection
This multicenter, randomized, double-blinded, placebo-controlled study will evaluate the effect of TU-100 on resolution of postoperative ileus (POI) in subjects undergoing open or laparoscopic bowel resection (BR).
- Trial name
- NCT04742907
- Testing
- TU-100
- Where
- 36 sites in United States
- Volunteers
- 402 people
- Sponsor
- Tsumura USA
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
Colorectal Cancer
Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00112918
- Testing
- Bevacizumab, Capecitabine, 5-Fluorouracil (5-FU)
- Where
- United States
- Volunteers
- 3,451 people
- Sponsor
- Hoffmann-La Roche
Crohn Disease
A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery
The main aim is to see if TAK-018 reduces the recurrence of intestinal inflammation after abdominal resection surgery in adults with Crohn's disease.
- Trial name
- NCT03943446
- Testing
- TAK-018
- Where
- 41 sites in United States, Austria and 3 more
- Volunteers
- 34 people
- Sponsor
- Takeda
Colon Cancer, Colon Polyp
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
For patients with colon polyps (clumps of cells in the lining of the colon) treatment often requires removal of the affected portion of the colon.
- Conditions
- Colon Cancer, Colon Polyp, Diverticular Diseases, Inflammatory Bowel Diseases
- Trial name
- NCT04703829
- Testing
- VI-RASD use in minimally invasive right or left colectomy, Right or Left colectomy
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Virtual Incision Corporation
Obstructive Defecation Syndrome, Chronic Constipation
Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)
The primary purpose of this study is to determine how effective and how durable STARR (stapled transanal rectal resection) surgery is in relieving symptoms of intractable constipation associated with obstructive defecation…
- Conditions
- Obstructive Defecation Syndrome, Chronic Constipation, Rectocele, Intussusception
- Trial name
- NCT00256984
- Testing
- Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler
- Where
- 7 sites in United States
- Volunteers
- 75 people
- Sponsor
- Ethicon Endo-Surgery
Crohn's Disease
A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
The purpose of this study is to evaluate the effectiveness of guselkumab treatment compared with placebo (an inactive substance with no medicine) in preventing recurrence of Crohn's disease in participants after surgery.
- Trial name
- PROGRESS (NCT05784129)
- Testing
- Guselkumab
- Where
- 11 sites in United States, Poland
- Volunteers
- 4 people
- Sponsor
- Janssen Research & Development, LLC
Ileus, Gastro-Intestinal Disorder
A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.
- Trial name
- INTEGRITY (NCT05470387)
- Testing
- LB1148
- Where
- 23 sites in United States
- Volunteers
- 23 people
- Sponsor
- Palisade Bio
Colorectal Carcinoma
Neoadjuvant Recombinant Vaccinia Virus for Metastatic Colorectal Cancer With Liver Resection
This is a neoadjuvant Phase 2a, open-label trial in patients with metastatic colorectal carcinoma who are undergoing a complete resection of the metastatic colorectal tumors in their liver.
- Trial name
- NCT01329809
- Testing
- Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
- Where
- Canada
- Volunteers
- 2 people
- Sponsor
- Jennerex Biotherapeutics