Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04519138
Status:
COMPLETED
Last Update Posted:
2021-12-02
First Post:
2020-08-17
Brief Title:
Investigation to Evaluate Safety and Efficacy of the Endodrill Model X Biopsy Instrument
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
Safety and Efficacy of the Endodrill Model X Biopsy Instrument When Sampling Tumours in the Upper Gastrointestinal Tract
Status:
COMPLETED
Status Verified Date:
2021-11
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:
None
Brief Summary:
This is an investigator led prospective open label investigation performed at three clinics in Sweden comparing the flexible endoscopic biopsy instrument Endodrill Model X with the standard sampling method endoscopic ultrasound fine needle aspirationbiopsy Assessment of safety is the primary objective and performance is the secondary objective
Detailed Description:
The investigation will include 20 patients with lesions and suspected tumors in the stomach esophagus or duodenum upper small intestine The investigation will consist of one visit with an endoscopic examination with sampling of an observed lesion or suspected tumor Six biopsies will be collected from each patient three consecutive samples using the Endodrill Model X instrument and three consecutive samples using the standard fine needle The order of instruments to be used will be randomly assigned The patient will be under observation for 2 hours after the procedure Telephone follow-up will be performed 1 and 7 days after the examination Visual confirmation of the biopsies size will be recorded at the examination If the samples verify a tumor or not will be evaluated at Day 14 when the pathology report is concluded
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