Ignite Creation Date:
2024-05-06 @ 12:06 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01483040
Status:
COMPLETED
Last Update Posted:
2012-11-08
First Post:
2011-11-22
Brief Title:
PeerScope B System Clinical Protocol
Sponsor:
PeerMedical Ltd
Organization:
PeerMedical Ltd
Study Overview
Official Title:
a Prospective Clinical Study to Establish the Usability of the PeerScope B System When Used During Standard Colonoscopy Procedure
Status:
COMPLETED
Status Verified Date:
2012-11
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:
The PeerScope B System by PeerMedical Ltd is intended to provide visualization via a video monitor and therapeutic access to the lower intestinal tract The lower intestinal tract includes but is not restricted to the organs tissues and subsystems large bowel and cecum The device is introduced rectally as with any standard colonoscope when indications consistent with the need for the procedure are observed in the adult patient population
The purpose of this prospective clinical study is to establish the usability of the PeerScope B System when used during standard colonoscopy procedure
The study population is comprised of patients indicated for colonoscopy
The primary endpoint is reaching the cecum of the colon with PeerScope B SystemSecondary endpoints
1 The first secondary endpoint is the incidence of complications using the PeerMedical colonoscope
2 The second secondary endpoint is successful therapeutic interventions as biopsies polypectomies APC etc
3 The third secondary endpoint is the procedure time
4 The fourth secondary endpoint is the subjective evaluation of the additional view angle by the physician
5 The fifth secondary endpoint is patient satisfactory
The purpose of this prospective clinical study is to establish the usability of the PeerScope B System when used during standard colonoscopy procedure
The study population is comprised of patients indicated for colonoscopy
The primary endpoint is reaching the cecum of the colon with PeerScope B SystemSecondary endpoints
1 The first secondary endpoint is the incidence of complications using the PeerMedical colonoscope
2 The second secondary endpoint is successful therapeutic interventions as biopsies polypectomies APC etc
3 The third secondary endpoint is the procedure time
4 The fourth secondary endpoint is the subjective evaluation of the additional view angle by the physician
5 The fifth secondary endpoint is patient satisfactory
Detailed Description:
Founded in 2009 PeerMedical develops colonoscopes capable of wide view angle at the press of the button The PeerScope B System is an endoscopic platform that enables the physician to get a wide angle view while maintaining all of the features commonly used during Gastrointestinal GI procedures with very limited learning curve and in service process The current standard devices have viewing limitations By adding this viewing functionality PeerMedical will potentially empower physicians to improve polyps detection and cancers within the colon
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