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COMPLETED

The Biologic Basis of Hernia Formation

NCT01099033 · View on ClinicalTrials.gov ↗

Study Summary

The study will examine potential biological and genetic mechanisms leading to hiatal and paraesophageal hernia formation in predisposed individuals. It is expected that these patients will have defects in the normal production and maturation of collagen and other connective tissue proteins, thus leading to weakness in the diaphragm that may allow for spontaneous herniation. Comparison of tissue and blood samples from these patients (study group) will be made to those from individuals undergoing lower esophageal surgery who have not developed a concurrent hernia (i.e. esophageal myotomy for achalasia and laparoscopic gastric bypass or laparoscopic adjustable gastric banding for morbid obesity - control group).

Study Locations (1)

Missouri

  • Washington University School of Medicine — St Louis

Trial Details

FieldValue
Enrollment Target 151 participants
Start Date 2007-08
Est. Completion 2011-10

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01099033

The ClinicalTrials.gov registry entry for NCT01099033 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,036 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Hiatal Hernia appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01099033 reports 1 study location spanning 1 distinct geographic area — top geographies include Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01099033 about?

NCT01099033 is a clinical study titled "The Biologic Basis of Hernia Formation". The study will examine potential biological and genetic mechanisms leading to hiatal and paraesophageal hernia formation in predisposed individuals. It is expected that these patients will have defects in the normal production and maturation of collagen and other connective tissue proteins, thus lea...

What is the current status of trial NCT01099033?

This trial is currently completed. The enrollment target is 151 participants. The study started on 2007-08. Estimated completion is 2011-10.

What conditions does trial NCT01099033 study?

This clinical trial studies the following conditions: Hiatal Hernia, Paraesophageal Hernia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT01099033?

This trial is sponsored by Washington University School of Medicine, which has 1,036 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01099033 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial