Research to Further Inform Thinking About the Role of LINX for Reflux Disease
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- STATUS
- Recruiting
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- End date
- Jul 31, 2032
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- participants needed
- 500
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- sponsor
- Ethicon Endo-Surgery
Summary
The RETHINK REFLUX Registry is a post-market prospective, multi-center, observation, single arm, long-term safety surveillance registry of subjects implanted with the LINX device. The primary objective of the study is to confirm the long-term safety profile of the LINX device and procedure (implant/explant) up to 10 years post-implant.
Description
The RETHINK REFLUX Registry or Research to further inform thinking about the role of LINX for Reflux Disease is sponsored by Ethicon Endo-Surgery, Inc. This is a post-market prospective, multi-center, observational, single arm, long-term safety surveillance registry of subjects implanted with the LINX device. Up to 500 subjects will be enrolled and implanted at up to 50 centers in both the US and selected countries outside the US with regulatory approval for the LINX Reflux Management System. The study will collect data from patients 10 years post implant. The primary objective of the study is to confirm the long-term safety profile of the LINX device and procedure (implant/explant). Secondary objectives include Effectiveness, Health Economics and Health Utilization.
Details
| Condition | Gastroesophageal Reflux |
|---|---|
| Treatment | LINX Reflux Management System |
| Clinical Study Identifier | NCT04253392 |
| Sponsor | Ethicon Endo-Surgery |
| Last Modified on | 23 October 2022 |
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