NCT03735862

Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH

Complications and 1-Year Outcomes Following Hiatal Hernia Repair With MIROMESH a Novel, Highly Vascular, Porcine Derived, Biologic Matrix

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 85 (actual)
• Sponsor: Miromatrix Medical Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Investigator will identify a consecutive cohort of patients who have undergone a hiatal hernia repair and are at least 6 months post index procedure.

Detailed description

Planned Sample Size: At minimum of 70 consecutive subjects at least 6-months post-index procedure Study Population: A consecutive cohort of patients who have undergone a hiatal hernia repair with MIROMESH. Primary Objective: Characterize the procedural and early post-operative safety profile of MIROMESH when used as reinforcement in hiatal hernia repair. Secondary Objectives A retrospective chart review will identify the appropriate cohort with a prospective follow-up survey to acquire safety and outcome information. A retrospective chart review of appropriate subjects. Data to be acquired will be: Preoperative - Chart Review * Gender * Date of birth * Weight * Body Mass Index * Specific diagnosis * DeMeester Score * 24 hour pH test (% acid exposure in 24 hours) * Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Score Peri-operative Preoperative - Chart Review * Date of surgery * Number of stitches used to close wound * Paraesophageal hernia type * Mesh shape * Mesh size used * Attachment technique * Length of stay * Complications Post-Operative (With-in 1 month of surgery) Preoperative - Chart Review * Complications (Mesh related) * Complications (procedure related) * Prolonged dysphagia (Y/N) * Stenosis (Y/N) * Dilations (Y/N) * Esophagogastroduodenoscopy or Upper gastrointestinal series documented hernia recurrence * GERD-HRQL Score Prospective institutional review board approved Follow-Up Telephone Interview * Have you had a revision surgery? * GERD-HRQL Score * How satisfied are you with the procedure? * Have you used proton pump inhibitors in the last 3 months * How likely are you to recommend this procedure to a loved one?

Conditions

• Hiatal Hernia With Gastroesophageal Reflux Disease
• Gastroesophageal Reflux
• GERD

Interventions

Type	Name	Description
BIOLOGICAL	Hepatic derived surgical matrix	Hiatal hernia repair with MIROMESH

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-06-01
• Completion: 2018-10-01
• First posted: 2018-11-08
• Last updated: 2019-10-01
• Results posted: 2019-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study