Clinical trials: Bowel Surgery
Open/ Laparoscopic/ Robotic Resection of the Colon
Collection of Electrophysiological Data During Colon Resection
The study is conducted to record continuous electrophysiological signals from intact and ischemic bowel tissue during colonic resection surgery, in order to train the Exero Medical Leak Detection System classification algorithm…
- Trial name
- NCT04854473
- Testing
- Exero Medical Leak Detection System
- Where
- Israel
- Volunteers
- 5 people
- Sponsor
- Exero Medical Ltd.
Rectal Cancer, Colon Cancer
Perfusion Assessment in Laparoscopic Left Anterior Resection
The purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess viability of colon tissue during laparoscopic…
- Conditions
- Rectal Cancer, Colon Cancer, Crohn's Disease, Polyp
- Trial name
- PILLAR II (NCT01560377)
- Testing
- PINPOINT Endoscopic Fluorescence Imaging System
- Where
- 11 sites in United States
- Volunteers
- 147 people
- Sponsor
- Novadaq Technologies ULC, now a part of Stryker
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.
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
Colorectal Cancer, Diverticular Diseases
Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon 25mm SFM system plus OTOLoc when used to create a side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal…
- Trial name
- Colonic (NCT07276529)
- Testing
- Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- GI Windows, Inc.
Anal Fistula
Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment with a Gel and Plug of Wharton's Jelly
The purpose of this open, multicenter pilot trial is to evaluate the tolerance of the combination of a gel and a plug made of Wharton's jelly in the treatment of ano-perineal fistulas resistant to surgical treatment.
- Trial name
- NCT05638139
- Testing
- SygeLIX-F + SygeLIX-G
- Where
- 2 sites in France
- Volunteers
- 9 people
- Sponsor
- TBF Genie Tissulaire
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
Colorectal Cancer
A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery
This study is open to people with newly diagnosed colorectal cancer. People who are scheduled for surgery can participate. People either get a medicine called BI 765063 combined with ezabenlimab or combined with pembrolizumab in…
- Trial name
- NCT05446129
- Testing
- Ezabenlimab, BI 765063, Pembrolizumab
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Boehringer Ingelheim
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.
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
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
Stoma Reversal Procedure
Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure
A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the anastomotic junction created during a stoma reversal procedure.
- Trial name
- NCT02196519
- Testing
- Sylys Surgical Sealant
- Volunteers
- 16 people
- Sponsor
- Cohera Medical, Inc.
Small Bowel Anastomosis
Functional Lumen Opening With Self-Forming Magnetic Anastomosis
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a small bowel anastomosis in subjects undergoing laparoscopic small bowel surgery.
- Trial name
- FLOWS (NCT06454916)
- Testing
- Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc
- Where
- 7 sites in United States
- Volunteers
- 79 people
- Sponsor
- GI Windows, Inc.
Crohns Disease, Fistula
A Study of Surgical Interventions in Fistulizing Conditions
In this study, participants with complex fistulizing conditions will be treated with surgical interventions according to their clinic's standard practice.
- Conditions
- Crohns Disease, Fistula, Rectovaginal Fistula, Complex Perianal Fistula
- Trial name
- NCT04940611
- Where
- 41 sites in United States, Austria and 8 more
- Volunteers
- 646 people
- Sponsor
- Takeda
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
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.
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy
This is a multi-site epidemiological study designed to monitor circulating tumor DNA (ctDNA) status in participants with Stage II (high risk)/III colorectal cancer (CRC) following resection/prior to adjuvant chemotherapy (AdCTx)…
- Trial name
- NCT04813627
- Testing
- Regular blood sample collection for ctDNA assessment
- Where
- 74 sites in United States, Belgium and 2 more
- Volunteers
- 2,079 people
- Sponsor
- BioNTech SE
Rectal Cancer
TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer
The purpose of this study is to determine if the addition of TNFerade™ to pre-operative chemoradiotherapy increases the number of pathologic complete responses when compared to pre-operative chemoradiotherapy alone as assessed…
- Trial name
- NCT00137878
- Testing
- TNFerade™
- Where
- United States
- Sponsor
- GenVec
Anastomosis, Surgical, Internal Hernia
MagDI U.S. Registry
Assess the incidence and severity of internal hernia and bowel obstruction at one year in a U.S. population following use of the MagDI System to create side-to-side duodeno-ileal anastomoses.
- Conditions
- Anastomosis, Surgical, Internal Hernia, Bowel Obstruction
- Trial name
- NCT06928545
- Testing
- Side-to-side duodenal-ileal anastomosis
- Where
- 6 sites in United States
- Volunteers
- 106 people
- Sponsor
- GT Metabolic Solutions, Inc.
Rectal Cancer Surgery
ColoSeal™ ICD System Anastomotic Protection Pivotal Study
The purpose of this clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current…
- Trial name
- NCT07429110
- Testing
- ColoSeal ICD System, Protective Diverting Ostomy
- Where
- 9 sites in United States, New Zealand
- Volunteers
- 250 people
- Sponsor
- Averto Medical, Inc.