Trial Outcomes & Findings for Miromatrix Biological Mesh for Hiatal Hernia Repair (NCT NCT02436681)

NCT ID: NCT02436681

Last Updated: 2019-09-20

Results Overview

Failure of the index hernia operation which requires another operative procedure to correct. Hernia recurrence was assessed with a barium upper gastrointestinal series or in some cases other imaging analysis to characterize the anatomy of the esophagus.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2019-09-20

Participant Flow

Subjects were recruited from treating surgeon's normal practice.

3 found to be ineligible (inclusion/exclusion) at surgery 2 Withdrew consent prior to surgery 2 Mesh not implanted per surgeon discretion 2 Canceled procedure

Participant milestones

Measure	MIROMESH MIROMESH was used for laparoscopic paraesophageal hernia repair
Overall Study STARTED	41
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	MIROMESH MIROMESH was used for laparoscopic paraesophageal hernia repair
Overall Study Lost to Follow-up	10
Overall Study Withdrawal by Subject	2
Overall Study Death	2

Baseline Characteristics

Miromatrix Biological Mesh for Hiatal Hernia Repair

Baseline characteristics by cohort

Measure	MIROMESH n=41 Participants MIROMESH was used for laparoscopic paraesophageal hernia repair
Age, Continuous	63.3 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants
ASA Status 1 - Healthy Patients	1 Participants n=5 Participants
ASA Status 2 - Mild to moderate systemic disease, controlled	23 Participants n=5 Participants
ASA Status 3 - Severe disease process, limited activity	14 Participants n=5 Participants
ASA Status Unknown	3 Participants n=5 Participants
BMI	30.7 kg/m^2 STANDARD_DEVIATION 4.0 • n=5 Participants
Smoking Status Current	1 Participants n=5 Participants
Smoking Status Ex-smoker	11 Participants n=5 Participants
Smoking Status Never	29 Participants n=5 Participants
Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL)	19.3 Score STANDARD_DEVIATION 13.5 • n=5 Participants
GERD-HRQL Global Assessment Satisfied	7 Participants n=5 Participants
GERD-HRQL Global Assessment Neutral	3 Participants n=5 Participants
GERD-HRQL Global Assessment Dissatisfied	29 Participants n=5 Participants
GERD-HRQL Global Assessment Unknown	2 Participants n=5 Participants
SF36 - Physical Component Summary Score	41.5 Score STANDARD_DEVIATION 9.9 • n=5 Participants
SF36 - Mental Component Summary Score	46.6 Score STANDARD_DEVIATION 12.0 • n=5 Participants
SF36 - Physical Functioning	38.9 Score STANDARD_DEVIATION 9.5 • n=5 Participants
SF36 - Social Functioning	42.5 Score STANDARD_DEVIATION 10.7 • n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Lost to follow up 10 Withdrew Consent 2 Death 2

Failure of the index hernia operation which requires another operative procedure to correct. Hernia recurrence was assessed with a barium upper gastrointestinal series or in some cases other imaging analysis to characterize the anatomy of the esophagus.

Outcome measures

Measure	MIROMESH n=27 Participants MIROMESH was used for laparoscopic paraesophageal hernia repair
Number of Subjects With a Hernia Recurrence Requiring Reoperation	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Lost to follow up 10 Withdrew Consent 2 Death 2

Reports the number of radiographic recurrence of hernia that does not require surgery and are generally asymptomatic. Hernia recurrence was assessed with a barium upper gastrointestinal series or in some cases other imaging analysis to characterize the anatomy of the esophagus.

Outcome measures

Measure	MIROMESH n=27 Participants MIROMESH was used for laparoscopic paraesophageal hernia repair
Radiographic Recurrence	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Lost to follow up 10 Withdrew Consent 2 Death 2

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).

Outcome measures

Measure	MIROMESH n=27 Participants MIROMESH was used for laparoscopic paraesophageal hernia repair
GERD-HRQL	3.8 Score Standard Deviation 5.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Lost to follow up 10 Withdrew Consent 2 Death 2

Same as baseline

Outcome measures

Measure	MIROMESH n=27 Participants MIROMESH was used for laparoscopic paraesophageal hernia repair
GERD-HRQL Global Assessment Satisfied	23 Participants
GERD-HRQL Global Assessment Neutral	2 Participants
GERD-HRQL Global Assessment Dissatisfied	1 Participants
GERD-HRQL Global Assessment Unknown	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Lost to follow up 10 Withdrew Consent 2 Death 2

Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Function, Role Physical, Bodily Pain, and General health which assess aspects of physical health. These are used to make an overall physical health score, the Physical Component Summary score (PCS). The higher the score the better the subject's physical health. Range from 0-100.

Outcome measures

Measure	MIROMESH n=27 Participants MIROMESH was used for laparoscopic paraesophageal hernia repair
SF36 - Physical Component Summary Score	47.2 Score Standard Deviation 9.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Vitality, Role Emotional, Social Functioning, and Mental health which assess aspects of Mental health. These are used to make an overall mental health score, the Mental Component Summary score (MCS). The higher the score the better the subject's mental health. Range from 0-100.

Outcome measures

Measure	MIROMESH n=27 Participants MIROMESH was used for laparoscopic paraesophageal hernia repair
SF36 - Mental Component Summary Score	53.6 Score Standard Deviation 8.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Same as baseline

Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Functioning which assess aspects of physical health. The higher the score the better the subject's physical health. Range from 0-100.

Outcome measures

Measure	MIROMESH n=27 Participants MIROMESH was used for laparoscopic paraesophageal hernia repair
SF36 - Physical Functioning	45.6 Score Standard Deviation 10.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Social Functioning which assess aspects of mental health. The higher the score the better the subject's physical health. Range from 0-100.

Outcome measures

Measure	MIROMESH n=27 Participants MIROMESH was used for laparoscopic paraesophageal hernia repair
SF36 - Social Functioning	49.5 Score Standard Deviation 8.8

Adverse Events

MIROMESH

Serious events: 2 serious events

Other events: 10 other events

Deaths: 2 deaths

Serious adverse events

Measure	MIROMESH n=41 participants at risk MIROMESH was used for laparoscopic paraesophageal hernia repair
Respiratory, thoracic and mediastinal disorders Acute respiratory distress	2.4% 1/41 • Number of events 2 • 2 years post procedure
Gastrointestinal disorders Nausea/vomiting	2.4% 1/41 • Number of events 1 • 2 years post procedure

Other adverse events

Measure	MIROMESH n=41 participants at risk MIROMESH was used for laparoscopic paraesophageal hernia repair
Gastrointestinal disorders Abdominal Pain	2.4% 1/41 • Number of events 1 • 2 years post procedure
Gastrointestinal disorders Diarrhea	2.4% 1/41 • Number of events 1 • 2 years post procedure
Gastrointestinal disorders Dysphagia	2.4% 1/41 • Number of events 1 • 2 years post procedure
Gastrointestinal disorders Edema at GE Junction	4.9% 2/41 • Number of events 2 • 2 years post procedure
Gastrointestinal disorders Food Bolus Obstruction	2.4% 1/41 • Number of events 1 • 2 years post procedure
Gastrointestinal disorders Acute Gastric Distension	2.4% 1/41 • Number of events 1 • 2 years post procedure
Gastrointestinal disorders Anterior Gastropexy Pain	2.4% 1/41 • Number of events 1 • 2 years post procedure
Blood and lymphatic system disorders Mild Hypoxia	2.4% 1/41 • Number of events 1 • 2 years post procedure
Gastrointestinal disorders Nausea and Vomiting	4.9% 2/41 • Number of events 2 • 2 years post procedure
General disorders Pleural Effusion requiring drainage	2.4% 1/41 • Number of events 1 • 2 years post procedure
General disorders Soreness	2.4% 1/41 • Number of events 1 • 2 years post procedure
Renal and urinary disorders Urinary Tract Infection	2.4% 1/41 • Number of events 1 • 2 years post procedure

Additional Information

Head of Clinical Affairs

Miromatrix

Phone: 952.942-6000

Email: mmacenski@miromatrix.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place