Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435533
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-03-14
Brief Title:
Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
coldAPC
Brief 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
Detailed Description:
Familial adenomatous polyposis FAP is an autosomal dominantly inherited disorder which results from a germ line mutation in the APC adenomatous polyposis coli gene FAP is characterized by the formation of very high number of colorectal adenomatous polyps which could cause the development of colorectal cancer in the 5th decade of life After colon surgery patients are still at risk of developing upper GI cancer eg in the duodenum Because of the continuing risk for the development of duodenal cancer regular endoscopic surveillance is recommended for these patients
In this study a new APC modality Precise mode E1 applied for the remission of FAP polyps during routine endoscopic surveillance is suggested Argonplasma coagulation APC is widely used for the ablation and coagulation of superficial lesions in the GI tract The application of high thermal tissue destroying APC in the duodenum is challenging due to the anatomy of the duodenal wall which is thin and therefore susceptible to thermal damage
The application of low-thermal argonplasma in the GI tract could be just as useful as it was suggested for the treatment of neoplastic tissue in gynecology Low-thermal APC using Erbe Standard 32 mm FiAPC probe and Precise mode was successfully applied for the remission of cervical intraepithelial neoplasia The formation of reactive oxygen and nitric oxide species has been discussed as trigger for the effect on neoplasia tissue of low-thermal argonplasma
Regarding current knowledge this is the first application of this APC modality in the GI tract
In this study a new APC modality Precise mode E1 applied for the remission of FAP polyps during routine endoscopic surveillance is suggested Argonplasma coagulation APC is widely used for the ablation and coagulation of superficial lesions in the GI tract The application of high thermal tissue destroying APC in the duodenum is challenging due to the anatomy of the duodenal wall which is thin and therefore susceptible to thermal damage
The application of low-thermal argonplasma in the GI tract could be just as useful as it was suggested for the treatment of neoplastic tissue in gynecology Low-thermal APC using Erbe Standard 32 mm FiAPC probe and Precise mode was successfully applied for the remission of cervical intraepithelial neoplasia The formation of reactive oxygen and nitric oxide species has been discussed as trigger for the effect on neoplasia tissue of low-thermal argonplasma
Regarding current knowledge this is the first application of this APC modality in the GI tract
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None