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NCT04282720 · ClinicalTrials.gov registry record · NA
SurgiMend Mesh at the Hiatus
A NA study, sponsored by Kettering Health Network.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT04282720 is a NA study that has completed, run by Kettering Health Network. The registered enrollment target is 9 participants.
The verdict
NCT04282720, a NA study, has completed, sponsored by Kettering Health Network.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study Summary
Prospective, single-arm, open-label study to evaluate re-occurrence and quality of life in subjects undergoing primary Hiatal hernia repair using SurgiMend biological mesh. Up to 15, with a target of 10, subjects are planned to be enrolled at one site. All subjects will receive the SurgiMend mesh during surgery. Data collected will be compared to historical data. Subjects will complete a pre-operative visit. After surgery, in addition to any standard of care visits, subjects will complete 3- and 6-month follow-ups involving a phone QOL survey and will have an upper GI series at 6 months.
Interventions
- DEVICE SurgiMend Mesh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-03-31 |
| Est. Completion | 2023-09-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04282720
The ClinicalTrials.gov registry entry for NCT04282720 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kettering Health Network, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SurgiMend Mesh is the first listed.
NCT04282720 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04282720 about?
NCT04282720 is a clinical study titled "SurgiMend Mesh at the Hiatus". Prospective, single-arm, open-label study to evaluate re-occurrence and quality of life in subjects undergoing primary Hiatal hernia repair using SurgiMend biological mesh. Up to 15, with a target of 10, subjects are planned to be enrolled at one site. All subjects will receive the SurgiMend mesh du...
What is the current status of trial NCT04282720?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2020-03-31. Estimated completion is 2023-09-05.
What interventions are being tested in trial NCT04282720?
The interventions under investigation include: SurgiMend Mesh (DEVICE).
Who is sponsoring clinical trial NCT04282720?
This trial is sponsored by Kettering Health Network, which has 14 total clinical trials registered on ClinicalTrials.gov.
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