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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 is a NA study that has completed, run by University of Washington. The registered enrollment target is 20 participants.
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.
Interventions
- DEVICE Veritas® Collagen Matrix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-05 |
| Est. Completion | 2013-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01195545
The ClinicalTrials.gov registry entry for NCT01195545 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Veritas® Collagen Matrix is the first listed.
NCT01195545 reports 0 study locations.
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.
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