Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-31 @ 8:18 AM
Study NCT ID:
NCT07026357
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2022-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of 3D-planimetry on Optimized Therapeutic Assessment in Complex Benign Esophageal Stenosis
Sponsor:
Thomas Seufferlein
Organization:
Study Overview
Official Title:
Impact of 3D-planimetry on Optimized Therapeutic Assessment in Complex Benign Esophageal Stenosis; a Prospective Multi-center Study
Status:
COMPLETED
Status Verified Date:
2025-06
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:
INTENSE
Brief Summary:
Esophageal stenosis has a high impact on patients quality of live and food intake affecting personal nutrition status and general health.
For benign strictures of the esophagus, endoscopic dilatation therapy is recommended by actual guidelines.
Since the extent of dilatation is currently directed by endoscopic view and fluoroscopic imaging, patients are exposed to radiation and the determination of the appropriate extent of dilatation is difficult.
Therefore, the aim of this study is to compare the effect of 3D-planimetric measurement with current fluoroscopic monitoring on the success of endoscopic esophageal dilatation therapy in patients with benign esophageal stenosis.
For benign strictures of the esophagus, endoscopic dilatation therapy is recommended by actual guidelines.
Since the extent of dilatation is currently directed by endoscopic view and fluoroscopic imaging, patients are exposed to radiation and the determination of the appropriate extent of dilatation is difficult.
Therefore, the aim of this study is to compare the effect of 3D-planimetric measurement with current fluoroscopic monitoring on the success of endoscopic esophageal dilatation therapy in patients with benign esophageal stenosis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: