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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIROMESH | Other | Single-arm study. MIROMESH will be used in the surgical repair of hiatal hernias. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIROMESH | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| GERD-HRQL |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Rosen, M.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States | ||
| Monmouth Medical Center |
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
Subjects were recruited from treating surgeon's normal practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | MIROMESH | MIROMESH was used for laparoscopic paraesophageal hernia repair |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MIROMESH | MIROMESH was used for laparoscopic paraesophageal hernia repair |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Lost to follow up 10 Withdrew Consent 2 Death 2 | Posted | Count of Participants | Participants | 2 years |
|
|
2 years post procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MIROMESH | MIROMESH was used for laparoscopic paraesophageal hernia repair | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
This study was not a randomized controlled trial, thus direct comparisons to no treatment or other treatment cannot be made.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Affairs | Miromatrix | 952.942-6000 | mmacenski@miromatrix.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2015 | Jun 7, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006551 | Hernia, Hiatal |
| ID | Term |
|---|---|
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
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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). |
| 2 years |
| GERD-HRQL Global Assessment | Same as baseline | 2 years |
| 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. | 2 years |
| 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. | 2 years |
| 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. | 2 years |
| 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. | 2 years |
| Long Branch |
| New Jersey |
| 07740 |
| United States |
| Carolinas Healthcare System | Charlotte | North Carolina | 28204 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Virginia Heartburn and Hernia Institute | Lorton | Virginia | 22079 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ASA Status | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Smoking Status | Count of Participants | Participants |
|
| Gastroesophageal Reflux Disease Health Related Quality of Life (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). | Mean | Standard Deviation | Score |
|
| GERD-HRQL Global Assessment | Global rating of how satisfied patients are with their condition. | Count of Participants | Participants |
|
| SF36 - Physical Component Summary Score | 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. | Mean | Standard Deviation | Score |
|
| SF36 - Mental Component Summary Score | 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. | Mean | Standard Deviation | Score |
|
| SF36 - Physical Functioning | 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. | Mean | Standard Deviation | Score |
|
| SF36 - Social Functioning | 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. | Mean | Standard Deviation | Score |
|
|
|
| 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. | Lost to follow up 10 Withdrew Consent 2 Death 2 | Posted | Count of Participants | Participants | 2 years |
|
|
|
| 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). | Lost to follow up 10 Withdrew Consent 2 Death 2 | Posted | Mean | Standard Deviation | Score | 2 years |
|
|
|
|
| Other Pre-specified | GERD-HRQL Global Assessment | Same as baseline | Lost to follow up 10 Withdrew Consent 2 Death 2 | Posted | Count of Participants | Participants | 2 years |
|
|
|
| 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. | Lost to follow up 10 Withdrew Consent 2 Death 2 | Posted | Mean | Standard Deviation | Score | 2 years |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Score | 2 years |
|
|
|
| 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. | Same as baseline | Posted | Mean | Standard Deviation | Score | 2 years |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Score | 2 years |
|
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|
|
| 41 |
| 2 |
| 41 |
| 10 |
| 41 |
| Nausea/vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Edema at GE Junction | Gastrointestinal disorders | Systematic Assessment |
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| Food Bolus Obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Acute Gastric Distension | Gastrointestinal disorders | Systematic Assessment |
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| Anterior Gastropexy Pain | Gastrointestinal disorders | Systematic Assessment |
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| Mild Hypoxia | Blood and lymphatic system disorders | Systematic Assessment |
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| Nausea and Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Pleural Effusion requiring drainage | General disorders | Systematic Assessment |
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| Soreness | General disorders | Systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
|