Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-01 @ 5:15 AM
Study NCT ID:
NCT01921933
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2013-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Optiflow Patency and Maturation Study
Sponsor:
Bioconnect Systems, Inc
Organization:
Study Overview
Official Title:
The "OPEN" Study Optiflow PatEncy and MaturatioN
Status:
COMPLETED
Status Verified Date:
2016-01
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:
OPEN
Brief Summary:
The objective of this study is to assess the performance and safety of the Optiflow Anastomotic Connector (Optiflow) when used to facilitate the creation of autogenous arteriovenous fistula (AVF) anastomoses.
Detailed Description:
The investigation is designed as a multi-center, prospective, single-arm, clinical study of the Optiflow performance and safety in a maximum of 180 subjects which includes one (1) roll-in subjects per investigator (maximum of 36 roll-in subjects). Subjects will be followed at 14 days post-procedure, 42 days post-procedure, and 90 days post-procedures.
Results will be compared to a pre-established performance goal.
Up to fifteen (15) investigational sites will participate in the investigational study.
The primary performance endpoint is the overall maturation percentage rate at 90 days. Maturation is defined as an access site which achieves a diameter of greater or equal to 4 mm and blood flow greater or equal t0 500 mL/min as measured via duplex ultrasound.
The primary safety endpoint is a composite endpoint of serious adverse events known to be associated with arteriovenous fistula anastomosis surgical procedures through 90 days.
Results will be compared to a pre-established performance goal.
Up to fifteen (15) investigational sites will participate in the investigational study.
The primary performance endpoint is the overall maturation percentage rate at 90 days. Maturation is defined as an access site which achieves a diameter of greater or equal to 4 mm and blood flow greater or equal t0 500 mL/min as measured via duplex ultrasound.
The primary safety endpoint is a composite endpoint of serious adverse events known to be associated with arteriovenous fistula anastomosis surgical procedures through 90 days.
Study Oversight
Has Oversight DMC:
True
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?: