Lacrimal Duct ObstructionCANALHEMONCT02851641
Risk and Importance of Peroperative Nasal Hemorrhage in the Treatment of Lacrimal Duct Obstruction in Young Children
An observational study of Lacrimal Duct Obstruction, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The aim of the study is to evaluate the risk in intra-operative nasal hemorrhage when using a "pushed" probe (Master Ka) in the treatment of naso lacrimal duct obstruction (NLDO). In the investigator's experience, this risk seemed to minus using a pushed probe rather than the classical pulled-type probes. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Lacrimal Duct Obstruction
- What is being tested?
- "pushed" mono-canaliculonasal intubation
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2015to 10 Dec 2019
- Phase
- Observational
- 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with congenital nasolacrimal duct obstruction
Who may be able to join
- < 6 years of age
- Unilateral lacrimal duct obstruction with programmed surgery
- Surgery scheduled wih a "pushed" mono-canaliculonasal intubation
- No opposition of parents for he participation of their child
Who cannot join
- Coagulation disorder
- Previous history of nasolacrimal intubation (homo or contra-lateral)
- Non covered by health insurance
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the risk in intra-operative nasal hemorrhage when using a "pushed" probe (Master Ka) in the treatment of naso lacrimal duct obstruction (NLDO).
In the investigator's experience, this risk seemed to minus using a pushed probe rather than the classical pulled-type probes.
A lower risk of hemorrhage could lead to a change in the anesthetic procedure. The gold standard in NLDO is the use of an orotracheal intubation. It could then be replaced by the use of an orolaryngeal mask. A forthcoming study will evaluate the results of this anesthetic change.
- Conditions
- Lacrimal Duct Obstruction
- Being tested
- "pushed" mono-canaliculonasal intubation
- Medical subject headings
- Lacrimal Duct Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"pushed" mono-canaliculonasal intubationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Nasolacrimal duct obstruction | Not described Receives: Procedure: "pushed" mono-canaliculonasal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal hemorrhage
Measured: Through surgery completion, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study start2 Sep 2015
- Primary completion11 Sep 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lacrimal Duct ObstructionStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851641
- Sponsor's protocol ID
- CEN_2015_9
- Acronym
- CANALHEMO
- Status last verified
- Dec 2019
- First submitted
- 28 Jul 2016
- Last updated
- 11 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk and Importance of Peroperative Nasal Hemorrhage in the Treatment of Lacrimal Duct Obstruction in Young Children
- ClinicalTrials.gov ID
- NCT02851641
- Acronym / sponsor ID
- CANALHEMO / CEN_2015_9
- Conditions
- Lacrimal Duct Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 2 Sep 2015 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 1 Aug 2016 (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.
The aim of the study is to evaluate the risk in intra-operative nasal hemorrhage when using a "pushed" probe (Master Ka) in the treatment of naso lacrimal duct obstruction (NLDO).
In the investigator's experience, this risk seemed to minus using a pushed probe rather than the classical pulled-type probes.
A lower risk of hemorrhage could lead to a change in the anesthetic procedure. The gold standard in NLDO is the use of an orotracheal intubation. It could then be replaced by the use of an orolaryngeal mask. A forthcoming study will evaluate the results of this anesthetic change.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasolacrimal duct obstruction | – | Procedure: "pushed" mono-canaliculonasal intubation |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with congenital nasolacrimal duct obstruction
Key inclusion criteria (4 listed)
- < 6 years of age
- Unilateral lacrimal duct obstruction with programmed surgery
- Surgery scheduled wih a "pushed" mono-canaliculonasal intubation
- No opposition of parents for he participation of their child
Key exclusion criteria (3 listed)
- Coagulation disorder
- Previous history of nasolacrimal intubation (homo or contra-lateral)
- Non covered by health insurance
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 |
|---|---|---|
| "pushed" mono-canaliculonasal intubation | Procedure or surgery | Nasolacrimal duct obstruction |
Primary outcome
Nasal hemorrhage
Time frame: Through surgery completion, an average of 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
Related trials for Lacrimal Duct Obstruction
RecruitingPhase 3
Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated With Radioactive Iodine for Thyroid Cancer
Nasolacrimal Duct Obstruction, Thyroid Cancer
Active, not recruitingPhase 4
Efficacy and Safety of Piclosept in the Complex Treatment of Neonatal Dacryocystitis
Neonatal Dacryocystitis, Congenital Nasolacrimal Duct Obstruction
Not yet recruiting
Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction.
Nasolacrimal Duct Obstruction, Epiphora
Not yet recruiting
Outcomes of Early Lacrimal Probing Versus Lacrimal Sac Massage in Infants With Congenital Nasolacrimal Duct Obstruction
Lacrimal Duct Obstruction
Recruiting
Efficacy Evaluation of 5-Fluorouracil as an Adjuvant to Endoscopic Dacryocystorhinostomy in Managing Primary Acquired Nasolacrimal Duct Obstruction With Small Lacrimal Sac: A Randomized Controlled Study
Primary Acquired Nasolacrimal Duct Obstruction
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?
An observational study of Lacrimal Duct Obstruction, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 11 Dec 2019. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Nasal hemorrhage (time frame: Through surgery completion, an average of 1 hour). It is what the study was designed to measure, not a finding.
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 11 Dec 2019.