Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-31 @ 5:20 AM
Study NCT ID:
NCT04825457
Status:
UNKNOWN
Last Update Posted:
2021-04-01
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Anchoring-tip vs. Conventional EMR of Colorectal Polyps
Sponsor:
Kyungpook National University Chilgok Hospital
Organization:
Study Overview
Official Title:
Comparative Study of Anchoring-tip vs. Conventional EMR of Intermediate-Size Colorectal Polyps: Multi-center, Prospective, Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
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:
None
Brief Summary:
Endoscopic mucosal resection (EMR) is an effective and has been widely used technique for the treatment of superficial colorectal neoplasms. Although, conventional EMR (CEMR) showed high efficacy for the management of colorectal superficial neoplasms, there is problematic limitation in this technique - incomplete resection. In literature, the anchoring-tip EMR (AEMR), named as "Tip-in EMR" was first introduced in 2016 from Japan. Recently, several retrospective studies have been suggested about the effectiveness of AEMR. However, there has been no prospective randomized controlled study to identify its advantage over CEMR. Therefore, the investigators performed a multicenter randomized controlled trial to estimate the effectiveness of AEMR compared with CEMR for the endoscopic treatment of intermediate-size (10 to 20 mm) colorectal polyps.
Detailed Description:
After injection of normal saline solution mix, snaring was tried for CEMR. In AEMR, the snare tip was projected from the sheath by 1-2 mm length. Consequently, a small mucosal incision was made at proximal side of lesion. Then the snare was deployed progressively and adjusted around the lesion trying to obtain free margins. At the final step of both conventional and Tip-in EMR, the lesion was resected.
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?: