Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603298
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Evaluation of the Efficacy and Safety of Endoscopic Dilatation and Biological Therapy in Intestinal Stenosis Due to CD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of Endoscopic Dilatation Combined With Biological Therapy Therapy for the Treatment of Intestinal Stenosis in Patients With Crohns Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
All patients with Crohn39s disease already undergoing biological therapy for the treatment of clinically significant intestinal stenosis andor already undergoing endoscopic balloon dilatation during the period January 2016 - June 2024 will be enrolled
Detailed Description:
All patients meeting all inclusion criteria and no exclusion criteria will be offered participation in the study upon presentation of the information form and signing of the informed consent for participation in the study Each patient will be assigned a progressive identification number ID
All clinical data will be recorded for all patients
Demographic data age sex smoking habits
Montreal classification
Duration of disease
History of previous surgery
Past and current drug therapy
All available data on stenosis characteristics will be recorded
Localisation ileal ileo-caecal colic anastomotic
Extent mm
Evidence of concurrent endoscopic disease activity locally
All data related to the endoscopic procedure will also be recorded
Size of device used
Maximum dilatation achieved mm
Technical success assessed by endoscopic clearance of the stenosis after the dilation procedure
Consensual local steroid injection
Possible multiple endoscopic dilation sessions
The occurrence of episodes of intestinal sub-occlusion or occlusion will be recorded the introduction of steroid therapy and the need for surgery Where available radiological and endoscopic re-evaluation data will be recorded
Any changes in treatment and any adverse events defined as any adverse event will also be recorded as any adverse event without a necessary causal relationship with the endoscopic procedure and the concomitant ongoing biological therapy
All clinical data will be recorded for all patients
Demographic data age sex smoking habits
Montreal classification
Duration of disease
History of previous surgery
Past and current drug therapy
All available data on stenosis characteristics will be recorded
Localisation ileal ileo-caecal colic anastomotic
Extent mm
Evidence of concurrent endoscopic disease activity locally
All data related to the endoscopic procedure will also be recorded
Size of device used
Maximum dilatation achieved mm
Technical success assessed by endoscopic clearance of the stenosis after the dilation procedure
Consensual local steroid injection
Possible multiple endoscopic dilation sessions
The occurrence of episodes of intestinal sub-occlusion or occlusion will be recorded the introduction of steroid therapy and the need for surgery Where available radiological and endoscopic re-evaluation data will be recorded
Any changes in treatment and any adverse events defined as any adverse event will also be recorded as any adverse event without a necessary causal relationship with the endoscopic procedure and the concomitant ongoing biological therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None