Hiatal Hernia
Conditions
Brief summary
Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived from the highly vascularized porcine liver. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. This study will serve to provide clinicians with high-quality clinical data in order to provide them with a higher degree of confidence when selecting MIROMESH for hiatal hernia repair.
Interventions
DEVICEMIROMESH
Sponsors
Miromatrix Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* between 18 and 80 years old on the day of study enrollment * able and willing to sign the consent form and comply with all study visits and procedures * able to undergo elective laparoscopic hiatal hernia repair * free of cognitive or speech impairment * documented, symptomatic type II or III hernia ≥5cm in the axial/vertical dimension * commit to non-smoking for at least 4 weeks prior to procedure
Exclusion criteria
* previous operation of the esophagus or stomach * sensitivity to porcine material * pregnant or plan to be pregnant within next 2 years * immunocompromised or at risk of immunosuppression (i.e. be HIV positive, be experiencing organ rejection, be a recent or anticipated chemotherapy recipient) as determined by the Investigator * require emergent operation for acute gastric volvulus or strangulation * American Society of Anesthesiology (ASA) class 4 or greater * BMI ≥40 * life expectancy of less than 2 years at the time of enrollment * associated gastrointestinal disease that requires extensive medical or surgical intervention that might interfere with the quality of life assessment (e.g. Crohn's disease) * any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Hernia Recurrence Requiring Reoperation | 2 years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| GERD-HRQL | 2 years | 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). |
| GERD-HRQL Global Assessment | 2 years | Same as baseline |
| SF36 - Physical Component Summary Score | 2 years | 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. |
| Radiographic Recurrence | 2 years | 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. |
| SF36 - Physical Functioning | 2 years | 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. |
| SF36 - Social Functioning | 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. |
| SF36 - Mental Component Summary Score | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from treating surgeon's normal practice.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| MIROMESH MIROMESH was used for laparoscopic paraesophageal hernia repair | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | MIROMESH |
|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 12.5 |
| ASA Status 1 - Healthy Patients | 1 Participants |
| ASA Status 2 - Mild to moderate systemic disease, controlled | 23 Participants |
| ASA Status 3 - Severe disease process, limited activity | 14 Participants |
| ASA Status Unknown | 3 Participants |
| BMI | 30.7 kg/m^2 STANDARD_DEVIATION 4 |
| Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) | 19.3 Score STANDARD_DEVIATION 13.5 |
| GERD-HRQL Global Assessment Dissatisfied | 29 Participants |
| GERD-HRQL Global Assessment Neutral | 3 Participants |
| GERD-HRQL Global Assessment Satisfied | 7 Participants |
| GERD-HRQL Global Assessment Unknown | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 7 Participants |
| SF36 - Mental Component Summary Score | 46.6 Score STANDARD_DEVIATION 12 |
| SF36 - Physical Component Summary Score | 41.5 Score STANDARD_DEVIATION 9.9 |
| SF36 - Physical Functioning | 38.9 Score STANDARD_DEVIATION 9.5 |
| SF36 - Social Functioning | 42.5 Score STANDARD_DEVIATION 10.7 |
| Smoking Status Current | 1 Participants |
| Smoking Status Ex-smoker | 11 Participants |
| Smoking Status Never | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 41 |
| other Total, other adverse events | 10 / 41 |
| serious Total, serious adverse events | 2 / 41 |
Outcome results
Primary
Number of Subjects With a Hernia Recurrence Requiring Reoperation
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.
Time frame: 2 years
Population: Lost to follow up 10 Withdrew Consent 2 Death 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MIROMESH | Number of Subjects With a Hernia Recurrence Requiring Reoperation | 0 Participants |
Other Pre-specified
GERD-HRQL
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).
Time frame: 2 years
Population: Lost to follow up 10 Withdrew Consent 2 Death 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIROMESH | GERD-HRQL | 3.8 Score | Standard Deviation 5.3 |
p-value: <0.0001t-test, 1 sided
Other Pre-specified
GERD-HRQL Global Assessment
Same as baseline
Time frame: 2 years
Population: Lost to follow up 10 Withdrew Consent 2 Death 2
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MIROMESH | GERD-HRQL Global Assessment | Satisfied | 23 Participants |
| MIROMESH | GERD-HRQL Global Assessment | Neutral | 2 Participants |
| MIROMESH | GERD-HRQL Global Assessment | Dissatisfied | 1 Participants |
| MIROMESH | GERD-HRQL Global Assessment | Unknown | 1 Participants |
Other Pre-specified
Radiographic Recurrence
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.
Time frame: 2 years
Population: Lost to follow up 10 Withdrew Consent 2 Death 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MIROMESH | Radiographic Recurrence | 3 Participants |
Other Pre-specified
SF36 - Mental Component Summary Score
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.
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIROMESH | SF36 - Mental Component Summary Score | 53.6 Score | Standard Deviation 8 |
Other Pre-specified
SF36 - Physical Component Summary Score
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.
Time frame: 2 years
Population: Lost to follow up 10 Withdrew Consent 2 Death 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIROMESH | SF36 - Physical Component Summary Score | 47.2 Score | Standard Deviation 9.3 |
p-value: =0.0468t-test, 1 sided
Other Pre-specified
SF36 - Physical Functioning
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.
Time frame: 2 years
Population: Same as baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIROMESH | SF36 - Physical Functioning | 45.6 Score | Standard Deviation 10.6 |
p-value: =0.014t-test, 1 sided
Other Pre-specified
SF36 - Social Functioning
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.
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIROMESH | SF36 - Social Functioning | 49.5 Score | Standard Deviation 8.8 |
p-value: =0.018t-test, 1 sided