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Trial · NCT07913490

Short-term Application of Lactoferrin Ventilation Tubes

NCT07913490, Not applicable, Not yet recruiting, Second Affiliated Hospital, Zhejiang University, School of Medicine

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Short-term Application of Lactoferrin Ventilation Tubes. Trials, record NCT07913490. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07913490

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Short-term Application of Lactoferrin Ventilation Tubes
NCT number
NCT07913490
Status
Not yet recruiting
Phases
Not applicable
Enrollment
20 participants, estimated
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Conditions
Otitis Media With Effusion (OME)
Interventions
Ventilation tube insertion
First posted
2026-11-03
Last updated
2026-11-03

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber and Percentage of Participants at Each Score on the Study-Defined 5-Point Intraoperative Feasibility Scale for Placement and Removal of the Lactoferrin Tympanostomy TubeFrom the first attempt at tympanostomy tube insertion to 10 minutes after the successful placement of the tube.
For each participant's single study ear, placement and removal will be rated separately on the same study-defined 5-point ordinal scale: 1 (very smooth), first-attempt success without additional manipulation; 2 (basically smooth), first-attempt success with minor adjustment; 3 (partially impeded), success after 2-3 attempts or minor instrument assistance; 4 (difficult), success only after changing instruments, enlarging the tympanic membrane incision, or 4 or more attempts; 5 (failed), unable to complete placement or removal. Lower scores indicate better feasibility. If removal is not attempted because placement failed, removal will be not applicable and will not be imputed.
PrimaryNumber and Percentage of Participants With Any New or Worsened Tympanic Membrane Local Reaction During Temporary Intraoperative Use of the Lactoferrin Tympanostomy TubeFrom the first attempt at tympanostomy tube insertion to 10 minutes after the successful placement of the tube.
For the single study ear of each participant, the investigator will assess tympanic membrane hyperemia, edema, bleeding, exudation, and any other local reaction after attempted placement, during the temporary dwell period, and immediately after tube removal. A participant will be counted once as having the outcome if at least one reaction is newly observed or worsens from the pre-placement assessment. The number and percentage of participants meeting this definition, with a two-sided 95% exact Clopper-Pearson confidence interval, will be reported using the safety analysis set, defined as all participants in whom placement of the lactoferrin tympanostomy tube is attempted. Each reaction type and severity will also be summarized separately. Multiple reaction types in the same participant will count once in the overall incidence.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07913490

GET https://conductscience.org/api/trials/v1/NCT07913490/registered