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Investigator will identify a consecutive cohort of patients who have undergone a hiatal hernia repair and are at least 6 months post index procedure.
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
Post-Operative (With-in 1 month of surgery) Preoperative - Chart Review
Prospective institutional review board approved Follow-Up Telephone Interview
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observations Group | Patients who have undergone a hiatal hernia repair with MIROMESH. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatic derived surgical matrix | Biological | Hiatal hernia repair with MIROMESH |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Required a Revision of the Index Surgery. | Patient self-report if they had a revision or other laparoscopic surgery following index procedure. | 6-18 months post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL) | 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. | 6-18 months post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction With Procedure | Patients reported their satisfaction with the procedure as "Dissatisfied", "Neutral", or Satisfied. | 6-18 Months post index procedure |
| Likelihood to Recommend | 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). |
Inclusion Criteria:
Exclusion Criteria:
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Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study
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| Name | Affiliation | Role |
|---|---|---|
| George K Gillian, M.D. | Virginia Heartburn and Hernia Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Heartburn and Hernia Institute | Lorton | Virginia | 22079 | United States |
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12 patients declined participation or could not be contacted. These were included in the baseline analysis.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Observations Group | Patients who have undergone a hiatal hernia repair with MIROMESH. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
85 patients were identified - 73 agreed to participate and enrolled, the entire cohort was analyzed at baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | Observations Group | Patients who have undergone a hiatal hernia repair with MIROMESH. Hepatic derived surgical matrix: Hiatal hernia repair with MIROMESH |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Who Required a Revision of the Index Surgery. | Patient self-report if they had a revision or other laparoscopic surgery following index procedure. | 12 patients declined participation or could not be contacted. | Posted | Count of Participants | Participants | 6-18 months post index procedure |
|
|
Operative & Peri-Operative, from admission for the surgical event through discharge. (Median length of stay 1 day)
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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 | Observations Group | Patients who have undergone a hiatal hernia repair with MIROMESH. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver lobe tear | Surgical and medical procedures | Systematic Assessment |
This was a retrospectively identified cohort.
| 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 | Jul 24, 2017 | Jun 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Medication Use | Use of PPIs in 3-months prior to follow-up interview | 6-18 months post index procedure |
| 6-18 Months post index procedure |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| GERD-HRQL | 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). | Mean | Standard Deviation | Score |
|
| Proton Pump Inhibitor Use | Count of Participants | Participants |
|
|
| Secondary | Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL) | 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. | 12 patients declined participation or could not be contacted. | Posted | Mean | Standard Deviation | Score | 6-18 months post index procedure |
|
|
|
|
| Secondary | Medication Use | Use of PPIs in 3-months prior to follow-up interview | 12 patients declined participation or could not be contacted. One patient did not answer. | Posted | Count of Participants | Participants | 6-18 months post index procedure |
|
|
|
|
| Other Pre-specified | Satisfaction With Procedure | Patients reported their satisfaction with the procedure as "Dissatisfied", "Neutral", or Satisfied. | 12 patients declined participation or could not be contacted. | Posted | Count of Participants | Participants | 6-18 Months post index procedure |
|
|
|
| Other Pre-specified | Likelihood to Recommend | 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). | 12 patients declined participation or could not be contacted. | Posted | Count of Participants | Participants | 6-18 Months post index procedure |
|
|
|
| 0 |
| 73 |
| 0 |
| 73 |
| 3 |
| 73 |
| Minor bleeding gastric vessels | Surgical and medical procedures | Systematic Assessment |
|
| Arterial flutter | Surgical and medical procedures | Systematic Assessment |
|
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| D004066 | Digestive System Diseases |