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This is a phase II clinical study to investigate the safety and efficacy of endoscopic antireflux mucosectomy (ARMS) for treatment of GERD.
The objective of the study is to establish the clinical efficacy and safety of ARMS for treatment of GERD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antireflux Mucosectomy | Experimental | Antireflux mucosectomy targeted at resection of gastric cardia muocsa to induce fibrosis and improve on the flap value over the gastroesophageal junction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antireflux Mucosectomy | Procedure | ARMS aimed at resection of mucosa at gastric cardia to induce fibrosis and tighten the gastroesophageal junction and reduce acid reflux |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Gastro Esophageal Reflux symptoms | GERD symptoms evidence by the improvement in the Gastroesophageal Reflux Quality of Life (QoL) of ≥50% compared to the baseline off Proton Pump Inhibitors (PPI) value 3 months after the procedure | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | Success in resection of mucosa at cardia by ARMS | 1 day |
| 24 hour pH study post ARMS | 24 hour pH study | 3 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip Wai Yan Chiu, MD, FRCSEd | Contact | +85235053952 | philipchiu@surgery.cuhk.edu.hk | |
| Man Yee Yung | Contact | +85235052956 | myyung@surgery.cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combined Endoscopy Center, Prince of Wales Hospital | Recruiting | Hong Kong | 00000 | Hong Kong |
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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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| High resolution Manometry | HRM | 3 and 12 months |
| Gastroesophageal junction classified by Hill's classification | endoscopic assessment of Gastroesophageal junction | 3 and 12 months |
| D004066 | Digestive System Diseases |