Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06153901
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-01
First Post:
2023-11-22
Brief Title:
Endoloop Mediated Cardioplication to Treat Gastroesophageal Reflux Disease
Sponsor:
Qilu Hospital of Shandong University
Organization:
Qilu Hospital of Shandong University
Study Overview
Official Title:
Metal Clip and Endoloop Mediated Endoscopic Cardioplication ECLC for the Treatment of Gastroesophageal Reflux Disease GERDa Prospective Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Endoscopic full-thickness plication EFTP of cardiafundus has been shown effective in treating GERD patients However EFTP requires proprietary equipment that are not available in many countries Here we designed a metal clip and endoloop mediated cardioplication ECLC procedure to achieve EFTP
Detailed Description:
Endoscopic full thickness pancreatography EFTP is a minimally invasive surgical method that has emerged in recent years for the treatment of severe gastroesophageal reflux disease This surgery requires the use of disposable patented instruments which is expensive and has not entered the domestic market To this end we have innovatively developed an endoloop mediated cardioplication ECLC that only requires metal clips and nylon ropes The most common and inexpensive endoscopic consumables can achieve the effect of tightening the lower esophageal sphincter which is expected to be used for the treatment of gastroesophageal reflux disease The ECLC surgery first incises the mucosa and submucosa on the small curvature side and posterior side approximately 34 of the total circumference of the diaphragm level cardia until smooth muscle fibers are exposed Fix the metal clip covered with nylon rope on the exposed smooth muscle layer and finally tighten the nylon rope to achieve full folding of the cardia After the surgery the patient fasted overnight and received intravenous PPI treatment On the second day after surgery a fluid diet was restored and discharge was possible ECLC is simple easy to operate relatively inexpensive and minimally invasive and is expected to become a new method for treating severe gastroesophageal reflux disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None