Hiatal Hernia With Gastroesophageal Reflux DiseaseNCT03735862
Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH
An observational study of Hiatal Hernia With Gastroesophageal Reflux Disease and Gastroesophageal Reflux, run by Miromatrix Medical Inc. at 1 site in United States.
Trial summary
Investigator will identify a consecutive cohort of patients who have undergone a hiatal hernia repair and are at least 6 months post index procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hiatal Hernia With Gastroesophageal Reflux Disease, Gastroesophageal Reflux, GERD
- What is being tested?
- Hepatic derived surgical matrix
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 1 Oct 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study
Who may be able to join
- Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Heartburn and Hernia Institute
Lorton, Virginia, 22079
About this study
Official title: Complications and 1-Year Outcomes Following Hiatal Hernia Repair With MIROMESH a Novel, Highly Vascular, Porcine Derived, Biologic Matrix
Investigator will identify a consecutive cohort of patients who have undergone a hiatal hernia repair and are at least 6 months post index procedure.
Read the detailed description
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
- Gender
- Date of birth
- Weight
- Body Mass Index
- Specific diagnosis
- DeMeester Score
- 24 hour pH test (% acid exposure in 24 hours)
- Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Score Peri-operative Preoperative - Chart Review
- Date of surgery
- Number of stitches used to close wound
- Paraesophageal hernia type
- Mesh shape
- Mesh size used
- Attachment technique
- Length of stay
- Complications
Post-Operative (With-in 1 month of surgery) Preoperative - Chart Review
- Complications (Mesh related)
- Complications (procedure related)
- Prolonged dysphagia (Y/N)
- Stenosis (Y/N)
- Dilations (Y/N)
- Esophagogastroduodenoscopy or Upper gastrointestinal series documented hernia recurrence
- GERD-HRQL Score
Prospective institutional review board approved Follow-Up Telephone Interview
- Have you had a revision surgery?
- GERD-HRQL Score
- How satisfied are you with the procedure?
- Have you used proton pump inhibitors in the last 3 months
- How likely are you to recommend this procedure to a loved one?
- Being tested
- Hepatic derived surgical matrix
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic derived surgical matrixBiological
Also called MIROMESH Biologic Matrix
Hiatal hernia repair with MIROMESH
| Study group | Role | What they receive |
|---|---|---|
| Observations Group | Patients who have undergone a hiatal hernia repair with MIROMESH. Receives: Biological: Hepatic derived surgical matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-18 months post index procedure
Secondary outcomes (2)
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.
Measured: 6-18 months post index procedure
Medication Use
Use of PPIs in 3-months prior to follow-up interview
Measured: 6-18 months post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Jun 2017
- Primary completion1 Jun 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hiatal Hernia With Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miromatrix Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George K Gillian, M.D., Principal investigator, Virginia Heartburn and Hernia Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735862
- Sponsor's protocol ID
- 20174001
- Status last verified
- Sep 2019
- First submitted
- 7 Nov 2018
- Last updated
- 1 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications and 1-Year Outcomes Following Hiatal Hernia Repair With MIROMESH a Novel, Highly Vascular, Porcine Derived, Biologic Matrix
- ClinicalTrials.gov ID
- NCT03735862
- Acronym / sponsor ID
- 20174001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Miromatrix Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Posted 5 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigator will identify a consecutive cohort of patients who have undergone a hiatal hernia repair and are at least 6 months post index procedure.
Detailed description
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
- Gender
- Date of birth
- Weight
- Body Mass Index
- Specific diagnosis
- DeMeester Score
- 24 hour pH test (% acid exposure in 24 hours)
- Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Score Peri-operative Preoperative - Chart Review
- Date of surgery
- Number of stitches used to close wound
- Paraesophageal hernia type
- Mesh shape
- Mesh size used
- Attachment technique
- Length of stay
- Complications
Post-Operative (With-in 1 month of surgery) Preoperative - Chart Review
- Complications (Mesh related)
- Complications (procedure related)
- Prolonged dysphagia (Y/N)
- Stenosis (Y/N)
- Dilations (Y/N)
- Esophagogastroduodenoscopy or Upper gastrointestinal series documented hernia recurrence
- GERD-HRQL Score
Prospective institutional review board approved Follow-Up Telephone Interview
- Have you had a revision surgery?
- GERD-HRQL Score
- How satisfied are you with the procedure?
- Have you used proton pump inhibitors in the last 3 months
- How likely are you to recommend this procedure to a loved one?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observations Group | – | Biological: Hepatic derived surgical matrixPatients who have undergone a hiatal hernia repair with MIROMESH. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study
Key inclusion criteria (1 listed)
- Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatic derived surgical matrixAlso: MIROMESH Biologic MatrixHiatal hernia repair with MIROMESH | Biological | Observations Group |
Primary outcome
Number of Subjects Who Required a Revision of the Index Surgery.
Time frame: 6-18 months post index procedure
Patient self-report if they had a revision or other laparoscopic surgery following index procedure.
2 secondary outcomes
Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL)
Time frame: 6-18 months post index procedure
Medication Use
Time frame: 6-18 months post index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hiatal Hernia With Gastroesophageal Reflux Disease
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
Active, not recruiting
Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
GERD, Hiatal Hernia
Not yet recruiting
Antireflux Surgery Without Preoperative Esophageal Manometry
GERD, Hiatal Hernia
Recruiting
Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.
Hiatal Hernia, Paraesophageal, Hiatal Hernia Large
Not yet recruiting
Comparison of Laparoscopic Nissen Fundoplication and Hill-Snow Repair for Hiatus Hernia With Endoscopic Evaluation
Hiatal Hernia With Gastroesophageal Reflux Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George K Gillian, M.D. principal investigator
Virginia Heartburn and Hernia Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiatal Hernia With Gastroesophageal Reflux Disease and Gastroesophageal Reflux, run by Miromatrix Medical Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Who Required a Revision of the Index Surgery. (time frame: 6-18 months post index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.