Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-02 @ 10:51 AM
Study NCT ID:
NCT03438695
Status:
UNKNOWN
Last Update Posted:
2018-02-20
First Post:
2018-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Motorized Spiral Enteroscopy Trial
Sponsor:
Evangelisches Krankenhaus Düsseldorf
Organization:
Study Overview
Official Title:
Total Motorized Spiral Enteroscopy Trial
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
NOT_YET_RECRUITING
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:
TMSET
Brief Summary:
Study design Prospective bicentric non-controlled clinical trial
Study purpose
\- to evaluate the efficacy and safety of Novel Motorized Spiral Enteroscopy (NMSE) for total enteroscopy in patients with suspected small bowel diseases with an indication for direct visualization of the entire small bowel
Primary objective
Rate of total enteroscopy by means of NMSE with:
1. a complete anterograde approach
2. or a combined anterograde and retrograde approach
Secondary objectives
* Procedural success of anterograde and retrograde approach
* Procedural time (minutes)
* Depth of maximum insertion (cm)
* Diagnostic yield
* Therapeutic yield
* Adverse events
Study purpose
\- to evaluate the efficacy and safety of Novel Motorized Spiral Enteroscopy (NMSE) for total enteroscopy in patients with suspected small bowel diseases with an indication for direct visualization of the entire small bowel
Primary objective
Rate of total enteroscopy by means of NMSE with:
1. a complete anterograde approach
2. or a combined anterograde and retrograde approach
Secondary objectives
* Procedural success of anterograde and retrograde approach
* Procedural time (minutes)
* Depth of maximum insertion (cm)
* Diagnostic yield
* Therapeutic yield
* Adverse events
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: