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Sponsoring company ceased business operations
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The purpose of this study is to collect post-marketing data on patient outcomes and satisfaction following treatment with the Plicatorâ„¢. The outcomes will be tracked through analysis of patient Quality of Life (QoL) questionnaires and medication use. The QoL and medication use questionaires will be administered and documented twice before the procedure and then again at outlined intervals following the procedure. Additionally, financial measures will be evaluated (i.e. pre-procedural and procedural time and costs, staffing/personnel needs during procedure, anesthesia and related costs, recovery time and associated cost, etc.) and post-procedure GERD-related medical history questionnaires will be completed.
This post-market evaluation is a multi-center study design using the NDO Surgical, Inc. Plicator as the treatment device. Treatment efficacy will be evaluated by comparing QoL and medication use before and after treatment with the device. Patient follow-ups will be completed at 1 week and at 6, 12, 24, 36, 48 and 60 months post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Active Plicator Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NDO Full-thickness Plicator | Device | A low-profile (≤6mm) gastroscope was advanced and an EGD followed by Savary wire placement was performed. The gastroscope was then removed and the Plicator was advanced directly over the wire and into the stomach. The gastroscope was re-introduced through the Plicator, and the Plicator was retroflexed under direct endoscopic visualization to the anterior gastric cardia, approximately 1cm below the gastroesophageal (GE) junction. The Plicator arms were opened and the endoscopic tissue retractor was advanced deeply into the gastric cardia. The gastric wall was then retracted into the open arms of the Plicator. The arms were closed and a single, transmural pledgeted suture was deployed. The Plicator and gastroscope were then removed and the gastroscope re-inserted to evaluate the post-plication GE junction. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | 6, 12, 24, 36, 48, 60 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| GERD Medication Use | 6, 12, 24, 36, 48, 60 months post-treatment | |
| Economic outcomes (e.g. procedure time/costs, staffing needs, anesthesia costs, recovery time/costs) | 6, 12, 24, 36, 48, 60 months post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center of Central Georgia | Macon | Georgia | 31201 | United States | ||
| Evanston Northwestern Healthcare |
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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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|
| Subject satisfaction | 6, 12, 24, 36, 48, 60 months post-treatment |
| Evanston |
| Illinois |
| 60201 |
| United States |
| Northside Gastroenterology, Inc. | Indianapolis | Indiana | 46260 | United States |
| Lenox Hill Hospital | New York | New York | 10021 | United States |
| Stony brook University Medical Center | Stony Brook | New York | 11794 | United States |
| Nashville Medical Research and the Maria Nathanson Center of Excellence | Nashville | Tennessee | 37205 | United States |
| Digestive Associates of Houston | Houston | Texas | 77030 | United States |
| D004066 | Digestive System Diseases |