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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02851641
Other study ID # CEN_2015_9
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2, 2015
Est. completion date December 10, 2019

Study information

Verified date December 2019
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date December 10, 2019
Est. primary completion date September 11, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Years
Eligibility Inclusion Criteria:

- < 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

Exclusion Criteria:

- Coagulation disorder

- Previous history of nasolacrimal intubation (homo or contra-lateral)

- Non covered by health insurance

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
"pushed" mono-canaliculonasal intubation


Locations

Country Name City State
France Fondation Ophtalmologique A. de Rothschild Paris

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nasal hemorrhage Through surgery completion, an average of 1 hour
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