Back to resultsAntireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux (ARMS)
Primary Purpose
Gastro Esophageal Reflux
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Antireflux Mucosectomy
Sponsored by
About this trial
This is an interventional treatment trial for Gastro Esophageal Reflux focused on measuring Antireflux Mucosectomy, GERD
Eligibility Criteria
Inclusion Criteria:
- Patients with typical symptoms of GERD with symptomatic response to PPI therapy for ≥ 3 months
- Hill's grade II and III of the gastroesophageal junction
- One of the following abnormalities in the objective assessment 3.1. Excessive acid exposure at the distal esophagus evidenced by 24 hour pH tests using % total time pH < 4 and / or DeMeester score 3.2. Endoscopic evidence of LA classes A,B,C or D esophagitis 3.3. Defective LES assessed by HRM with resting pressure of < 6mmHg or total length of less than 4cm or abdominal length of less than 2cm
Exclusion Criteria:
- Age > 70 yrs of < 18 yrs
- Pregnancy
- Any type of Hiatus hernia
- Patients with underlying malignancy
- ASA above grade III
Sites / Locations
- Combined Endoscopy Center, Prince of Wales HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Antireflux Mucosectomy
Arm Description
Antireflux mucosectomy targeted at resection of gastric cardia muocsa to induce fibrosis and improve on the flap value over the gastroesophageal junction
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Technical Success
Success in resection of mucosa at cardia by ARMS
24 hour pH study post ARMS
24 hour pH study
High resolution Manometry
HRM
Gastroesophageal junction classified by Hill's classification
endoscopic assessment of Gastroesophageal junction
Full Information
NCT ID
NCT04194723
First Posted
December 10, 2019
Last Updated
May 1, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04194723
Brief Title
Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux
Acronym
ARMS
Official Title
Phase II Clinical Study on the Safety and Efficacy of Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase II clinical study to investigate the safety and efficacy of endoscopic antireflux mucosectomy (ARMS) for treatment of GERD.
Detailed Description
The objective of the study is to establish the clinical efficacy and safety of ARMS for treatment of GERD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Esophageal Reflux
Keywords
Antireflux Mucosectomy, GERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antireflux Mucosectomy
Arm Type
Experimental
Arm Description
Antireflux mucosectomy targeted at resection of gastric cardia muocsa to induce fibrosis and improve on the flap value over the gastroesophageal junction
Intervention Type
Procedure
Intervention Name(s)
Antireflux Mucosectomy
Intervention Description
ARMS aimed at resection of mucosa at gastric cardia to induce fibrosis and tighten the gastroesophageal junction and reduce acid reflux
Primary Outcome Measure Information:
Title
Improvement in Gastro Esophageal Reflux symptoms
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Technical Success
Description
Success in resection of mucosa at cardia by ARMS
Time Frame
1 day
Title
24 hour pH study post ARMS
Description
24 hour pH study
Time Frame
3 and 12 months
Title
High resolution Manometry
Description
HRM
Time Frame
3 and 12 months
Title
Gastroesophageal junction classified by Hill's classification
Description
endoscopic assessment of Gastroesophageal junction
Time Frame
3 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with typical symptoms of GERD with symptomatic response to PPI therapy for ≥ 3 months
Hill's grade II and III of the gastroesophageal junction
One of the following abnormalities in the objective assessment 3.1. Excessive acid exposure at the distal esophagus evidenced by 24 hour pH tests using % total time pH < 4 and / or DeMeester score 3.2. Endoscopic evidence of LA classes A,B,C or D esophagitis 3.3. Defective LES assessed by HRM with resting pressure of < 6mmHg or total length of less than 4cm or abdominal length of less than 2cm
Exclusion Criteria:
Age > 70 yrs of < 18 yrs
Pregnancy
Any type of Hiatus hernia
Patients with underlying malignancy
ASA above grade III
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Wai Yan Chiu, MD, FRCSEd
Phone
+85235053952
Email
philipchiu@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Man Yee Yung
Phone
+85235052956
Email
myyung@surgery.cuhk.edu.hk
Facility Information:
Facility Name
Combined Endoscopy Center, Prince of Wales Hospital
City
Hong Kong
ZIP/Postal Code
00000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Chiu, MD
Phone
85226322627
Email
philipchiu@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Man Yee Yung
Phone
+85235052956
Email
myyung@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Philip WY Chiu, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux
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