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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: Completed NA study, sponsored by Kettering Health Network.
NCT04282720 is a NA study that has completed, run by Kettering Health Network. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Recurrence rate will be analyzed by a Upper gastrointestinal tract radiography (UGI) and clinical evaluation in conjunction with patient's reported physiological assessment per the GERD-HRQL.
Interventions
- DEVICE SurgiMend Mesh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-03-31 |
| Est. Completion | 2023-09-05 |
| Phase | NA |
What the finished NCT04282720 record still lists
NCT04282720 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which SurgiMend Mesh is the first listed.
NCT04282720 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04282720's enrollment target sits among peer trials
9 1975th of 2000 higher than 25 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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