NCT01022164

Brief Summary

To study the Safety and Efficacy of the use of fibrin glue in vitreoretinal surgery

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 surgery

Timeline
Completed

Started May 2009

Shorter than P25 for phase_4 surgery

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

November 29, 2009

Last Update Submit

May 29, 2024

Conditions

Keywords

fibrin gluevitrectomysafety and efficacy of fibrin glue

Study Arms (1)

fibrin glue

OTHER
Procedure: fibrin glue

Interventions

fibrin gluePROCEDURE
Also known as: Beriplast
fibrin glue

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Vitreorretinal procedures that require suture

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociacion para Evitar la Ceguera en Mexico

México, 04030, Mexico

Location

MeSH Terms

Interventions

Fibrin Tissue Adhesive

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2009

First Posted

December 1, 2009

Study Start

May 1, 2009

Primary Completion

November 1, 2009

Study Completion

April 1, 2010

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations