RecruitingNot ApplicableNCT06435533
Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
10 participants
Start Date
Dec 6, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria4
- 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 Criteria5
- 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
Interventions
DEVICElow energy argonplasma coagulation
see above
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06435533
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