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NCT06551077 · ClinicalTrials.gov registry record
Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair
A clinical trial of Paraesophageal Hernia, sponsored by University of Chicago.
- Recruiting
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT06551077 is a study of Paraesophageal Hernia that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 100 participants, roughly in line with the 99-participant average among 6 other Paraesophageal Hernia trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT06551077, a study of Paraesophageal Hernia, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will be a prospective observation study of the use of PoRSHA for repair in patients with challenging paraesophageal hernias. One of the most challenging problems facing foregut surgeons is the large and complex paraesophageal hernia (PEH) repair in the older patient. The investigator has demonstrated good outcomes and durability with the initial use of a novel permanent autologous vascularized biologic fascial flap to reconstruct the diaphragmatic hiatus following standard hiatal hernia repair in selected patients. This technique is called a posterior rectus sheath flap hiatal augmentation or PoRSHA, which is performed to enhance the hiatal repair for large (type III and IV) and recurrent PEH. The investigator believes by using the patient's autologous vascularized and peritonealized fascia at the hiatal defect, PoRSHA could increase the strength and restore the hiatal complex properties in ways that synthetic mesh, or a primary repair cannot. The hypothesis is that PoRSHA is a unique technique that has the potential to supplant current approaches to primary hiatal closure in select cases. By augmenting the hiatal closure with a vascularized fascial sheath, PoRSHA provides the tensile strength needed for the attenuated defects in large and complex PEHs.
Conditions Studied
Interventions
- PROCEDURE POSTERIOR RECTUS SHEATH HIATAL AUGMENTATION (PORSHA)
Study Locations (1)
Illinois
- The University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-05-15 |
| Est. Completion | 2029-05 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06551077
The ClinicalTrials.gov registry entry for NCT06551077 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 99-participant average among 6 other Paraesophageal Hernia trials with a reported enrollment target. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Paraesophageal Hernia appearing as the primary indexed condition, and to 1 intervention - of which POSTERIOR RECTUS SHEATH HIATAL AUGMENTATION (PORSHA) is the first listed.
NCT06551077 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT06551077 about?
NCT06551077 is a clinical study titled "Posterior Rectus Sheath Hiatal Augmentation in Paraesophageal Hernia Repair". This study will be a prospective observation study of the use of PoRSHA for repair in patients with challenging paraesophageal hernias. One of the most challenging problems facing foregut surgeons is the large and complex paraesophageal hernia (PEH) repair in the older patient. The investigator has...
What is the current status of trial NCT06551077?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2024-05-15. Estimated completion is 2029-05.
What conditions does trial NCT06551077 study?
This clinical trial studies the following conditions: Paraesophageal Hernia.
What interventions are being tested in trial NCT06551077?
The interventions under investigation include: POSTERIOR RECTUS SHEATH HIATAL AUGMENTATION (PORSHA) (PROCEDURE).
Who is sponsoring clinical trial NCT06551077?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06551077 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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