The feasibility and safety of eustachian tube dilation with a standard endovascular balloon: A clinical pilot study
Bibliographic record
Abstract
BACKGROUND: Obstructive eustachian tube dysfunction is a common pathology, generally accepted as the underlying cause for chronic ear diseases. Eustachian tube dilation has shown promising results in randomized controlled trials, but is a costly procedure. The aim of the current study was to assess the feasibility of transnasal balloon dilatation of the eustachian tube with an endovascular balloon in the context of ease of use, maneuverability, and safety. METHODS: Clinical pilot study carried out at a university tertiary care facility. In total, twelve patients, were included over a period of 6 months. All patients underwent tympanoplasty or tympanomastoidectomy surgeries. Eustachian tube dilation was carried out transnasal using an endovascular balloon. A computed tomography was carried out after surgery to assess for any potential damages and compared to preoperative imaging studies. Postoperative endoscopy was performed intraoperatively and at follow up to assess for any potential damages. RESULTS: All eustachian tube dilations were carried out successfully. No severe adverse events were noted during the procedure, in the postoperative period, or on imaging studies. Minor adverse events such as mild intraoperative bleeding was managed in a routine fashion. CONCLUSIONS: Balloon dilation of the eustachian tube with the endovascular balloon was feasible and safe in all cases. It is likely a more cost-effective alternative to commercially available balloons with similar designs and specifications. Trial registration The study was registered at clinicaltrials.gov; NCT04809753, initial release February 24th, 2021.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".