SurgeryPhase 4fibringlueNCT01022164
Use of Fibrin Glue in Vitreoretinalsurgery
A Phase 4 study testing fibrin glue in people with Surgery, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
To study the Safety and Efficacy of the use of fibrin glue in vitreoretinal surgery Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Surgery
- What is being tested?
- fibrin glue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- May 2009to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vitreorretinal procedures that require suture
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy in the Use of Fibrin Glue in Vitreoretinal Surgery
To study the Safety and Efficacy of the use of fibrin glue in vitreoretinal surgery
- Conditions
- Surgery
- Being tested
- fibrin glue
- Keywords
- fibrin glue, vitrectomy, safety and efficacy of fibrin glue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibrin glueProcedure or surgery
Also called Beriplast
| Study group | Role | What they receive |
|---|---|---|
| fibrin glue | Other | Not described Receives: Procedure: fibrin glue |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2009
- Study completionApr 2010
Why it stopped: Undefined
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022164
- Sponsor's protocol ID
- APEC0005
- Acronym
- fibringlue
- Status last verified
- May 2024
- First submitted
- 29 Nov 2009
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy in the Use of Fibrin Glue in Vitreoretinal Surgery
- ClinicalTrials.gov ID
- NCT01022164
- Acronym / sponsor ID
- fibringlue / APEC0005
- Conditions
- Surgery
- Keywords
- fibrin glue, vitrectomy, safety and efficacy of fibrin glue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Undefined
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- May 2009 (actual)
- Primary completion
- Nov 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the Safety and Efficacy of the use of fibrin glue in vitreoretinal surgery
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fibrin glue | Other | Procedure: fibrin glue |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Vitreorretinal procedures that require suture
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fibrin glueAlso: Beriplast | Procedure or surgery | fibrin glue |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Undefined). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fibrin glue in people with Surgery, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Undefined). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.