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RECRUITINGINTERVENTIONAL

Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The objective of this study is to investigate the feasibility for the treatment of precancerous peri-ampullary FAP polyps in the duodenum using low-thermal argonplasma.

Who May Be Eligible (Plain English)

Who May Qualify: - confirmed FAP disease - duodenal polyposis with recommendation of a follow-up EGD in 12 months corresponding to stage III (7-8 points) according to Spigelman - presence of duodenal polyps \< 10 mm - written willing to sign a consent form Who Should NOT Join This Trial: - presence of lesions that are suspicious of the presence of high-grade dysplasia or carcinoma - pregnancy or breastfeeding - severe general illnesses (permanent ASA (American Society of Anesthesiologists) III and IV) who do not prognostically benefit from follow-up, life expectancy \< 1 year - severe coagulopathy - any visible state of duodenal surface that makes APC treatment impossible, e.g. inflammation, stricture, stenosis or scarring changes/scar areas Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * confirmed FAP disease * duodenal polyposis with recommendation of a follow-up EGD in 12 months corresponding to stage III (7-8 points) according to Spigelman * presence of duodenal polyps \< 10 mm * written Informed Consent Exclusion Criteria: * presence of lesions that are suspicious of the presence of high-grade dysplasia or carcinoma * pregnancy or breastfeeding * severe general illnesses (permanent ASA (American Society of Anesthesiologists) III and IV) who do not prognostically benefit from follow-up, life expectancy \< 1 year * severe coagulopathy * any visible state of duodenal surface that makes APC treatment impossible, e.g. inflammation, stricture, stenosis or scarring changes/scar areas

Treatments Being Tested

DEVICE

low energy argonplasma coagulation

see above

Locations (1)

University Hospital Hamburg-Eppendorf
Hamburg, Germany