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NCT05716022 · ClinicalTrials.gov registry record
Hiatal Hernia and Pulmonary Involvement
A clinical trial, sponsored by University of Virginia.
- Completed
- Registry status
- 14
- Enrollment target
NCT05716022: Completed study, sponsored by University of Virginia.
NCT05716022 is a clinical trial that has completed, run by University of Virginia. The registered enrollment target is 14 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05716022 has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- 14 participants
- Enrollment target
Study Summary
Patients often present with a significant burden of fibrosis upon diagnosis as there is interest in identifying these individuals earlier in their disease course (i.e., "subclinical disease") where targeted treatments and modification of risk factors may curb their progression to fulminant fibrosing ILD. The investigators have investigated with computed tomography (CT) methods such as interstitial lung abnormalities (ILA) and high attenuation areas (HAAs) that may detect early radiological signs of interstitial lung inflammation and scarring and novel modifiable risk factors that contribute to its pathogenesis. Among adults without clinically-diagnosed pulmonary fibrosis, those with a hiatal hernia will have higher levels of pepsin in bronchoalveolar lavage fluid (BALF) compared with adults without a hiatal hernia. Secondarily, examinination on whether there are differences in other reflux contents from BALF including total bile, and peripheral biomarkers related to lung injury and fibrogenesis which include matrix metalloproteinase-7 (MMP-7), vascular cell adhesion molecule 1 (VCAM-1), and cancer antigen 125 (CA-125).
Primary Outcome
Investigators examine whether bronchoalveolar lavage fluid levels of pepsin are significantly different by case (adults with hiatal hernia and/or gastroesophageal reflux undergoing surgical repair) and control status (adults without hiatal hernia). Pepsin levels will be measured by ELISA assay.
Interventions
- DIAGNOSTIC_TEST Blood Collection
- DIAGNOSTIC_TEST Bronchoscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2023-01-05 |
| Est. Completion | 2025-12-31 |
What the finished NCT05716022 record still lists
NCT05716022 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 14 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Blood Collection is the first listed.
NCT05716022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05716022 about?
NCT05716022 is a clinical study titled "Hiatal Hernia and Pulmonary Involvement". Patients often present with a significant burden of fibrosis upon diagnosis as there is interest in identifying these individuals earlier in their disease course (i.e., "subclinical disease") where targeted treatments and modification of risk factors may curb their progression to fulminant fibrosing...
What is the current status of trial NCT05716022?
This trial is currently completed. The enrollment target is 14 participants. The study started on 2023-01-05. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT05716022?
The interventions under investigation include: Blood Collection (DIAGNOSTIC_TEST), Bronchoscopy (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05716022?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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