Ileostomy - Stoma Clinical Trial
Official title:
Pivotal Study to Evaluate the Safety and Efficacy of the Insides™ System in the Treatment of Subjects With a Double Enterostomy and/or Enterocutaneous Fistula and Type 2 Intestinal Failure.
This project aims to introduce and evaluate a novel assistive prosthetic system that helps prevent and treat nutrient and fluid loss from enterocutaneous fistulas. The device system functions simply to return the output from a fistula back into the distal limb of the intestine.
The development of enterocutaneous fistulas are devastating consequences of surgery or surgical diseases. They cause excessive fluid and nutrient losses from the gut resulting in severe dehydration and intestinal failure mandating invasive medical therapies to improve survival. These disorders inflict a vast burden of suffering, morbidity, and mortality on patients, while extracting enormous per-patient resources from healthcare systems. Parenteral nutrition is often required, meaning prolonged hospital stay, an attendant risk of line sepsis, venous damage and thrombosis, liver impairment, and death. There is a pressing demand for breakthrough technologies that can restore lost fluids and nutrients to the body in patients affected by enterocutaneous fistulas in order to reverse intestinal failure, eliminate the need for parenteral nutrition, prevent dehydration and renal injury, allow safe care in the community, enable chemotherapy completion, and restore quality of life. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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Early Closure Versus Conventional Closure in Postoperative Patients With Low Anteriresection for Rectal Cancer
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N/A | |
| Completed |
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|
N/A | |
| Completed |
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|
N/A | |
| Completed |
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Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives
|
N/A | |
| Completed |
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A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products
|
N/A | |
| Completed |
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Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece
|
N/A | |
| Completed |
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Digestibility of Selected Resistant Starches in Humans
|
N/A | |
| Completed |
NCT01994876 -
Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy
|
N/A | |
| Terminated |
NCT01994863 -
Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy
|
Phase 2 | |
| Completed |
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Assessement of the Peal Force Needed to Peel New Adhesives From the Skin
|
N/A | |
| Terminated |
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Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy
|
N/A | |
| Completed |
NCT02997267 -
Early Closure of Protective Ileostomy in Rectal Cancer Patients
|
N/A | |
| Recruiting |
NCT01880918 -
A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing
|
N/A | |
| Completed |
NCT01957397 -
Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy
|
N/A | |
| Terminated |
NCT03587519 -
Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery
|
N/A | |
| Recruiting |
NCT03872271 -
Is Diverting Loop Ileostomy Necessary in Completion Proctectomy With Ileal Pouch Anal- Anastomosis: A Multicentre, Randomized Study of the GETAID Chirurgie Group. IDEAL Trial
|
N/A | |
| Completed |
NCT04606004 -
Perianal Maceration in Pediatric Ostomy Closure Patients
|
N/A | |
| Completed |
NCT02886403 -
Evaluation of the Influence of Output on a Newly Develop Adhesive
|
N/A | |
| Recruiting |
NCT03424447 -
Stimulation of the Efferent Loop Before Loop Ileostomy Closure
|
Phase 2 | |
| Completed |
NCT03770078 -
Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
|
N/A |