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Ileostomy - Stoma clinical trials

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NCT ID: NCT01957462 Completed - Ileostomy - Stoma Clinical Trials

Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy

Start date: April 2013
Phase: N/A
Study type: Interventional

The aim of the current investigation is to develop new soft and more flexible 1-piece convex ostomy products.

NCT ID: NCT01957397 Completed - Ileostomy - Stoma Clinical Trials

Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy

Start date: October 2012
Phase: N/A
Study type: Interventional

To investigate the performance and safety of the three 2-piece convex ostomy appliances

NCT ID: NCT01957384 Completed - Ileostomy - Stoma Clinical Trials

Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care

Start date: February 2012
Phase: N/A
Study type: Interventional

To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured

NCT ID: NCT01939600 Completed - Ileostomy - Stoma Clinical Trials

Digestibility of Selected Resistant Starches in Humans

Start date: September 2013
Phase: N/A
Study type: Interventional

Dietary fiber is a type of carbohydrate which is not digested in the human small intestine. Whole grains are a source of dietary fiber that are used to promote health; however, using whole grains in commercial products results in a different taste and/or texture than the usual products made from refined grains. Thus, other types of high-fiber ingredients have been developed which can be incorporated into food products with less effect on their taste and/or texture. An example of this is resistant starch, defined as starch which is not digested in the human small intestine. The digestibility of starch is usually determined in-vitro; however, there is evidence that such methods may overestimate the amount of resistant starch by as much as 100%. The measurement of the amount of carbohydrate in the ileal effluent, digestive waste, of subjects with an ileostomy is considered to be the best in-vivo method of starch digestibility. The subjects collect ileal effluent during the day during which time they consume a polysaccharide-free diet. There is evidence that resistant starch consumed at breakfast is completely recovered in ileal effluent 8-10hr after consumption. The purpose of this study will be to compare the carbohydrate content recovered in ileal effluent of 10 subjects with a conventional ileostomy.

NCT ID: NCT01799239 Completed - Ileostomy - Stoma Clinical Trials

Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura

Start date: February 2013
Phase: N/A
Study type: Interventional

The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.

NCT ID: NCT01301417 Completed - Lymphoma Clinical Trials

Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis

RETROPRESS
Start date: February 2011
Phase: N/A
Study type: Observational

The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing™ device in routine clinical practice at a single center. The data will assist in further evaluating the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis. Hypothesis:The performance of the ColonRing™, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.

NCT ID: NCT01272869 Completed - Ileostomy - Stoma Clinical Trials

Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

Start date: January 2011
Phase: N/A
Study type: Interventional

The aim of the current clinical investigation is to evaluate a new filter

NCT ID: NCT01103466 Completed - Ileostomy - Stoma Clinical Trials

Investigation of the Performance of Ostomy Base Plate

Start date: April 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is that Atlas will do better than the two comparator products.