Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03735862
Recruitment Status : Completed
First Posted : November 8, 2018
Results First Posted : August 5, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Miromatrix Medical Inc.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Conditions Hiatal Hernia With Gastroesophageal Reflux Disease
Gastroesophageal Reflux
GERD
Intervention Biological: Hepatic derived surgical matrix
Enrollment 85
Recruitment Details A consecutive cohort of patients who underwent a hiatal hernia repair between 1 Nov 2015 and 1 Mar 2017 at the principle investigator's private practice were identified. Patients were contacted by phone and asked if they were willing to participate. If so they were consented and enrolled.
Pre-assignment Details 12 patients declined participation or could not be contacted. These were included in the baseline analysis.
Arm/Group Title Observations Group
Hide Arm/Group Description Patients who have undergone a hiatal hernia repair with MIROMESH.
Period Title: Overall Study
Started 73
Completed 73
Not Completed 0
Arm/Group Title Observations Group
Hide Arm/Group Description

Patients who have undergone a hiatal hernia repair with MIROMESH.

Hepatic derived surgical matrix: Hiatal hernia repair with MIROMESH

Overall Number of Baseline Participants 85
Hide Baseline Analysis Population Description
85 patients were identified - 73 agreed to participate and enrolled, the entire cohort was analyzed at baseline.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants
<=18 years
0
   0.0%
Between 18 and 65 years
63
  74.1%
>=65 years
22
  25.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 85 participants
55.9  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants
Female
55
  64.7%
Male
30
  35.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 85 participants
85
 100.0%
GERD-HRQL   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 85 participants
27.7  (9.3)
[1]
Measure Description: Measure Description: The Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) scale assess on symptoms associated with gastroesophageal reflux disease. There are 10 questions (each representing a GERD symptom such as heartburn) answered on a 6-point scale of 0 - 6 with 0 indicating no symptoms and 5 indicating incapacitating symptoms. The answer to all questions are summed to give you a final score on the scale. Scores may range for 0 (no symptoms) to 50 (incapacitating symptoms).
Proton Pump Inhibitor Use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants
Yes
73
  85.9%
No
12
  14.1%
1.Primary Outcome
Title Number of Subjects Who Required a Revision of the Index Surgery.
Hide Description Patient self-report if they had a revision or other laparoscopic surgery following index procedure.
Time Frame 6-18 months post index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
12 patients declined participation or could not be contacted.
Arm/Group Title Observations Group
Hide Arm/Group Description:
Patients who have undergone a hiatal hernia repair with MIROMESH.
Overall Number of Participants Analyzed 73
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL)
Hide Description The GERD-HRQL score assess the severity of GERD symptomatic and impact on the subjects quality of life. The score is comprised of 10 questions whose answers are summed for the final score. THe score can range from 0 to 50, with 50 being the worst and 0 meaning no impact.
Time Frame 6-18 months post index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
12 patients declined participation or could not be contacted.
Arm/Group Title Observations Group
Hide Arm/Group Description:
Patients who have undergone a hiatal hernia repair with MIROMESH.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: Score
7.1  (8.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Observations Group
Comments Difference between baseline and follow-up
Type of Statistical Test Other
Comments Paired t-Test
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
3.Secondary Outcome
Title Medication Use
Hide Description Use of PPIs in 3-months prior to follow-up interview
Time Frame 6-18 months post index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
12 patients declined participation or could not be contacted. One patient did not answer.
Arm/Group Title Observations Group
Hide Arm/Group Description:
Patients who have undergone a hiatal hernia repair with MIROMESH.
Overall Number of Participants Analyzed 72
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
7
   9.7%
No
65
  90.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Observations Group
Comments Difference between baseline and follow-up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Satisfaction With Procedure
Hide Description Patients reported their satisfaction with the procedure as "Dissatisfied", "Neutral", or Satisfied.
Time Frame 6-18 Months post index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
12 patients declined participation or could not be contacted.
Arm/Group Title Observations Group
Hide Arm/Group Description:
Patients who have undergone a hiatal hernia repair with MIROMESH.
Overall Number of Participants Analyzed 73
Measure Type: Count of Participants
Unit of Measure: Participants
Satisfied
63
  86.3%
Neutral
6
   8.2%
Dissatisfied
4
   5.5%
5.Other Pre-specified Outcome
Title Likelihood to Recommend
Hide Description Patients were asked to report how likely they would be to recommend this procedure to a friend or loved one with the same condition. Report was based on a scale of 1 (not at all likely) to 10 (very likely).
Time Frame 6-18 Months post index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
12 patients declined participation or could not be contacted.
Arm/Group Title Observations Group
Hide Arm/Group Description:
Patients who have undergone a hiatal hernia repair with MIROMESH.
Overall Number of Participants Analyzed 73
Measure Type: Count of Participants
Unit of Measure: Participants
<=3
3
   4.1%
>= 4 - <= 7
6
   8.2%
>=8
64
  87.7%
Time Frame Operative & Peri-Operative, from admission for the surgical event through discharge. (Median length of stay 1 day)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Observations Group
Hide Arm/Group Description Patients who have undergone a hiatal hernia repair with MIROMESH.
All-Cause Mortality
Observations Group
Affected / at Risk (%)
Total   0/73 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Observations Group
Affected / at Risk (%) # Events
Total   0/73 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Observations Group
Affected / at Risk (%) # Events
Total   3/73 (4.11%)    
Surgical and medical procedures   
Liver lobe tear   1/73 (1.37%)  1
Minor bleeding gastric vessels   1/73 (1.37%)  1
Arterial flutter   1/73 (1.37%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of Clinical Affairs
Organization: Miromatrix
Phone: 952.942-6000
EMail: mmacenski@miromatrix.com
Layout table for additonal information
Responsible Party: Miromatrix Medical Inc.
ClinicalTrials.gov Identifier: NCT03735862     History of Changes
Other Study ID Numbers: 20174001
First Submitted: November 7, 2018
First Posted: November 8, 2018
Results First Submitted: June 17, 2019
Results First Posted: August 5, 2019
Last Update Posted: October 1, 2019