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NCT01195545 · ClinicalTrials.gov registry record · NA
Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial
A NA study, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT01195545: Completed NA study, sponsored by University of Washington.
NCT01195545 is a NA study that has completed, run by University of Washington. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01195545, a NA study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is an investigator initiated pilot study to observe the short-term outcomes (a follow-up period of up to six months) of patients who undergo a laparoscopic paraesophageal Hiatal hernia (PEH) repair using the Veritas® Collagen Matrix brand biological mesh. This is a preliminary study at the University of Washington. A PEH occurs when the stomach protrudes through the diaphragm next to the esophagus. The chance of recurrence of a Hiatal hernia after laparoscopic PEH repair is between 20-40% within 6 months.During laparoscopic PEH repair, a mesh-type product is used as a scaffold. The mesh serves as a reinforcing material during the surgical repair. It is cut to the appropriate size needed for the hernia and sutured to the surrounding diaphragmatic tissue. There are many different types of meshes available on the market, and vary in the degree of manageability, strength, and adherence. Although surgical meshes work on the same principal, the variance between materials may affect patient outcomes. There is evidence that a biologic mesh, specifically one derived from Small Intestinal Submucosa (SIS), decreases the short-term (6-month) recurrence rates compared to a synthetic mesh or another type of biologic mesh. A biologic mesh, serving as a scaffold, will be replaced by the patient's own tissue after about 6 months. Theoretically, this would prevent the possible complications associated with synthetic mesh including mesh erosion into the esophagus or stricture of the esophagus. There are some case series showing similar short-term results between the different biologic meshes, but there is no direct comparative data.
Primary Outcome
Number of subjects experiencing recurrence greater than 2cm as well as 5cm post surgery.
Interventions
- DEVICE Veritas® Collagen Matrix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-05 |
| Est. Completion | 2013-12 |
| Phase | NA |
What the finished NCT01195545 record still lists
NCT01195545 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Veritas® Collagen Matrix is the first listed.
NCT01195545 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01195545 about?
NCT01195545 is a clinical study titled "Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial". This is an investigator initiated pilot study to observe the short-term outcomes (a follow-up period of up to six months) of patients who undergo a laparoscopic paraesophageal Hiatal hernia (PEH) repair using the Veritas® Collagen Matrix brand biological mesh. This is a preliminary study at the Univ...
What is the current status of trial NCT01195545?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2010-05. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01195545?
The interventions under investigation include: Veritas® Collagen Matrix (DEVICE).
Who is sponsoring clinical trial NCT01195545?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01195545's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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