Gastroesophageal Reflux Disease (GERD)ECCLNCT07176221
Endoscopic Cardial Constriction Ligation (ECCL) for Refractory GERD Using a Disposable Endoscope
A study testing endoscopic cardia constriction ligation in people with Gastroesophageal Reflux Disease (GERD), run by Ying Zhu at 1 site in China.
Trial summary
This study will recruit patients aged 18-80 with refractory gastroesophageal reflux disease (GERD). These patients had a disease course of more than six months, experienced typical symptoms such as acid reflux and heartburn, and had no symptom relief after taking a double dose of acid-suppressing medication for eight… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- endoscopic cardia constriction ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Age 18-80 years;
- (2) Disease duration ≥6 months, with typical symptoms such as acid regurgitation and heartburn, and a confirmed diagnosis of GERD;
- (3) GERD patients whose symptoms are not relieved after 8 weeks of continuous double-dose acid-suppressive therapy;
- (4) Willing to participate in the study and have signed the informed consent form.
Who cannot join
- (1) Patients with precancerous lesions such as early esophageal cancer or Barrett's esophagus >3 cm, or advanced upper gastrointestinal cancer identified on endoscopy;
- (2) Patients with hiatal hernia ≥2 cm, severe reflux esophagitis (LA-C or LA-D grade), esophageal or gastric varices, esophageal ulcer or stenosis, or a history of esophageal or gastric surgery;
- (3) Patients with esophageal motility disorders such as achalasia or diffuse esophageal spasm, rheumatic diseases such as systemic sclerosis or Sjögren's syndrome, or eosinophilic esophagitis;
- (4) Patients with a history of endoscopic or surgical anti-reflux procedures;
- (5) Patients with coagulation disorders, severe cardiopulmonary diseases, or inability to tolerate anesthesia, endoscopy, or treatment;
- (6) Women in the puerperium.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, 510515
About this study
Official title: Safety and Efficacy of Endoscopic Cardial Constriction Ligation （ECCL） With a Novel Disposable Endoscope: A Multicenter Randomized Controlled Trial
This study will recruit patients aged 18-80 with refractory gastroesophageal reflux disease (GERD). These patients had a disease course of more than six months, experienced typical symptoms such as acid reflux and heartburn, and had no symptom relief after taking a double dose of acid-suppressing medication for eight consecutive weeks. All eligible participants will undergo Endoscopic Cardial Constriction Ligation (ECCL) using a disposable endoscope. The procedure will follow a standardized protocol: mucosal and muscle layers of the cardia will be ligated at the lesser curvature, posterior wall, and greater curvature, with the ligated tissue at the greater curvature secured by a hemostatic clip. All patients will receive acid-suppressing therapy post-surgery and will be followed up at three and six months. The follow-ups will assess their GERD-Q scores, symptom relief, and incidence of complications.
Read the detailed description
Gastroesophageal reflux disease (GERD) is a common digestive disorder, with endoscopic manifestations including non-erosive reflux disease (NERD), reflux esophagitis (RE), and Barrett's esophagus (BE). Typical symptoms include heartburn and regurgitation, while atypical symptoms encompass chest pain, epigastric pain, belching, and extraesophageal symptoms. Epidemiological surveys in China indicate a prevalence of heartburn occurring at least once weekly ranging from 1.9% to 7.0%. Chronic, recurrent GERD significantly impairs patients' quality of life and may increase the risk of Barrett's esophagus, esophageal mucosal dysplasia, and esophageal adenocarcinoma. The etiology of GERD is complex, involving increased esophageal acid exposure, lower esophageal sphincter (LES) relaxation, low esophagogastric junction (EGJ) pressure, impaired esophageal clearance, hiatal hernia, and damage to the mucosal barrier by cytokines (e.g., IL-6, IL-8, platelet-activating factor PAF) and other factors.
Currently, the first-line treatment for GERD includes lifestyle modifications and oral acid-suppressive medications, such as proton pump inhibitors (PPIs) and potassium-competitive acid blockers (P-CABs). However, some patients with refractory GERD require long-term acid-suppressive therapy, and prolonged PPI use may increase the risk of Clostridioides difficile infection, community-acquired pneumonia, gastric cancer, and chronic kidney disease, while short-term P-CAB use may lead to hypergastrinemia [13]. According to the 2020 Chinese GERD Expert Consensus, for patients with refractory GERD who fail medical therapy, endoscopic or surgical treatment may be considered after excluding other causes and confirming evidence of reflux.
Traditional endoscopes are reusable and require cleaning and disinfection after each use, but complete sterilization may not always be achieved, posing a risk of cross-infection. In contrast, disposable endoscopes eliminate the risk of cross-infection, bypass the need for cleaning and disinfection, and reduce the incidence of instrument-related infections, while offering comparable functionality and operability to traditional endoscopes. Endoscopic cardia constriction ligation (ECCL) is an emerging endoscopic treatment technique, first performed by Professor Linghu Enqiang in 2013. This procedure involves ligating and fixing the mucosa and partial muscle layer above the dentate line under direct endoscopic visualization, creating mucosal folds. Post-procedure, the ligated mucosa undergoes ischemic necrosis and heals to form scar tissue, reducing the cardia diameter, increasing LES pressure, and alleviating reflux symptoms. ECCL is characterized by simple operation and minimal invasiveness, making it safer than traditional surgical procedures. Related complications, such as bleeding after ligation band detachment and retrosternal pain, are infrequent, resolve quickly, and no severe adverse events have been reported to date. However, the long-term efficacy of ECCL requires further validation.
Currently, there are no studies on the efficacy and safety of ECCL performed using disposable endoscopes. This study aims to conduct a randomized controlled trial to compare the effectiveness, safety, flexibility, and imaging clarity of ECCL performed with disposable versus traditional endoscopes in treating refractory GERD, providing scientific evidence to optimize treatment strategies and inform future GERD treatment guidelines.
Participants in this study will be randomly assigned to either the disposable endoscope group or the traditional endoscope group to undergo ECCL treatment. The primary objective is to compare the efficacy of ECCL performed with disposable versus traditional endoscopes in treating refractory GERD. Secondary objectives include: 1) Evaluating the observation clarity, flexibility, and compatibility of disposable endoscopes with surgical consumables; 2) Assessing the incidence of device failures and complications related to disposable endoscope-guided ECCL, such as mucosal injury, bleeding, and perforation.
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- endoscopic cardia constriction ligation
- Keywords
- Gastroesophageal Reflux Disease (GERD)., Endoscopic cardia constriction ligation (ECCL), novel disposable endoscope
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic cardia constriction ligationProcedure or surgery
The experimental group used disposable endoscopes to perform ECCL, while the control group used traditional endoscopes to perform ECCL. ECCL involves ligating and fixing the mucosa and partial muscle layer above the dentate line under direct endoscopic visualization to create folds. Post-procedure, the ligated mucosa undergoes ischemic necrosis and heals to form scar tissue, thereby reducing the cardia diameter, increasing LES pressure, and alleviating reflux symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group will undergo endoscopic cardia constriction ligation (ECCL) using disposable endoscopes. The procedure involves: under direct visualization, sequentially suctioning and ligating one ring each on the lesser curvature, posterior wall, and greater curvature of the cardia, capturing the mucosal and muscular layers. A hemostatic clip will be used to secure the base of the ligated tissue on the greater curvature. Six hours post-procedure, patients may consume lukewarm liquid or semi-liquid diets and continue acid-suppressive therapy for two weeks. Vital signs and any procedure-related serious adverse events will be recorded for statistical analysis. Receives: Procedure: endoscopic cardia constriction ligation |
| Control Group | Active comparator | The control group will undergo endoscopic cardia constriction ligation (ECCL) using traditional endoscopes. The procedure involves: under direct visualization, sequentially suctioning and ligating one ring each on the lesser curvature, posterior wall, and greater curvature of the cardia, capturing the mucosal and muscular layers. A hemostatic clip will be used to secure the base of the ligated tissue on the greater curvature. Six hours post-procedure, patients may consume lukewarm liquid or semi-liquid diets and continue acid-suppressive therapy for two weeks. Vital signs and any procedure-related serious adverse events will be recorded for statistical analysis. Receives: Procedure: endoscopic cardia constriction ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GERD-Q Score
Change in GERD-Q score (a validated questionnaire assessing GERD-related symptoms such as acid regurgitation and heartburn) from baseline, measured in patients undergoing ECCL with disposable endoscopes versus traditional endoscopes. GERD-Q scores are collected at baseline (pre-procedure via questionnaire and endoscopic examination), 3 months post-procedure, and 6 months post-procedure during follow-up visits.
Measured: From baseline before the procedure to 6 months post-procedure
Secondary outcomes (10)
Rate of Clinical Feasibility of ECCL Treatment Using Disposable Endoscopes
After passing through the cardia, the endoscope can be successfully inverted to observe the cardia, clearly visualizing the dentate line. During endoscopic cardia constriction ligation (ECCL), the ligation device can be securely attached to the endoscope, effectively suctioning the gastric wall mucosa and smoothly releasing the ligation ring. Additionally, all abnormal findings mentioned in the gastroscopy report should be photographed and documented.
If the entire gastroscopy examination and treatment are completed, it is considered feasible.
If the examination or treatment is interrupted due to issues with the endoscope itself, it is considered infeasible.
Calculation Formula: Clinical feasibility rate = (Number of participants completing the procedure successfully ÷ Total number of participants) × 100%Clinical feasibility rate of disposable endoscope ECCL treatment = (Number of participants completing the procedure successfully ÷ Total number of participants) × 100%.
Measured: From baseline before the procedure to 6 months post-procedure
Device Failure/Defect Rate
Observe whether the device experiences any malfunctions during the procedure, such as image interruption, blockage, or leakage during water delivery.
Measured: From baseline before the procedure to 6 months post-procedure
Number of Participants with Endoscope-Related Mucosal Injury
Document any occurrences of mucosal injury directly related to the use of disposable endoscopes during the ECCL procedure.
Measured: From baseline before the procedure to 1 hour post-procedure
Number of Participants with Gastrointestinal Perforation
Record any cases of gastrointestinal perforation occurring during or within 1 hour after the ECCL procedure using disposable endoscopes.
Measured: From baseline before the procedure to 1 hour post-procedure
Number of Participants with Significant Bleeding
Identify participants who experience significant bleeding during or within 1 hour post-procedure.
Measured: From baseline before the procedure to 1 hour post-procedure
Number of Participants with Procedure-Related Adverse Reactions
Track adverse reactions such as pain, bleeding, or infection occurring after the ECCL procedure.
Measured: From baseline before the procedure to 6 months post-procedure
Number of Participants With Clear Endoscopic Image Quality During ECCL Procedure
Image clarity will be assessed based on the ability to accurately identify the dentate line of the cardia.
Grade A: Brightness, contrast, and sharpness are sufficient to clearly identify the dentate line.
Grade B: Poor brightness, contrast, or sharpness prevents identification of the dentate line. Participants graded as "A" will be counted. Unit of Measure: Number of Participants
Measured: Time Frame: From baseline before the procedure to end of procedure
Number of Participants With Satisfactory Endoscope Flexibility During ECCL Procedure
Flexibility will be assessed based on the ability to perform retroflexion smoothly.
Grade A: Endoscope can be retroflexed smoothly.
Grade B: Endoscope cannot be retroflexed smoothly. Participants graded as "A" will be counted. Unit of Measure: Number of Participants
Measured: Time Frame: From baseline before the procedure to end of procedure
Number of Participants With Compatible Consumables During ECCL Procedure
Compatibility will be assessed based on successful attachment and operation of ligation devices.
Grade A: Endoscope is compatible with ligation device; procedure proceeds smoothly.
Grade B: Endoscope is incompatible with ligation device; procedure cannot proceed. Participants graded as "A" will be counted. Unit of Measure: Number of Participants
Measured: From baseline before the procedure to end of procedure
Composite Success Rate of ECCL Using Disposable Endoscopes
Composite success is defined as a case in which all three procedural parameters are graded as "A":
Image clarity sufficient to identify the dentate line of the cardia
Endoscope flexibility allowing smooth retroflexion
Compatibility of the endoscope with ligation devices enabling uninterrupted operation
If any parameter is graded "B", the case is considered unsuccessful. Success rate is calculated as: (Number of Successful Cases / Total Number of Participants in Group) × 100 Unit of Measure: Percentage of Participants
Measured: From baseline before the procedure to 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ying Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ying Zhu, Shenzhen Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176221
- Sponsor's protocol ID
- NYSZYYEC2025K055R002
- Acronym
- ECCL
- Status last verified
- Sep 2025
- First submitted
- 16 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li RH, Yang YY, Xu W, Xia GL, Cheng Q, Cui XB, Zhu Y, Bao XH. Efficacy and safety of endoscopic cardia constriction ligation with a single-use endoscope versus a reusable endoscope for refractory gastroesophageal reflux disease: protocol for a multicenter randomized controlled trial. Front Med (Lausanne). 2026 Jun 24;13:1832310. doi: 10.3389/fmed.2026.1832310. eCollection 2026.
PubMed 42422819
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Endoscopic Cardial Constriction Ligation （ECCL） With a Novel Disposable Endoscope: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07176221
- Acronym / sponsor ID
- ECCL / NYSZYYEC2025K055R002
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- Gastroesophageal Reflux Disease (GERD)., Endoscopic cardia constriction ligation (ECCL), novel disposable endoscope
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Ying ZhuUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will recruit patients aged 18-80 with refractory gastroesophageal reflux disease (GERD). These patients had a disease course of more than six months, experienced typical symptoms such as acid reflux and heartburn, and had no symptom relief after taking a double dose of acid-suppressing medication for eight consecutive weeks. All eligible participants will undergo Endoscopic Cardial Constriction Ligation (ECCL) using a disposable endoscope. The procedure will follow a standardized protocol: mucosal and muscle layers of the cardia will be ligated at the lesser curvature, posterior wall, and greater curvature, with the ligated tissue at the greater curvature secured by a hemostatic clip. All patients will receive acid-suppressing therapy post-surgery and will be followed up at three and six months. The follow-ups will assess their GERD-Q scores, symptom relief, and incidence of complications.
Detailed description
Gastroesophageal reflux disease (GERD) is a common digestive disorder, with endoscopic manifestations including non-erosive reflux disease (NERD), reflux esophagitis (RE), and Barrett's esophagus (BE). Typical symptoms include heartburn and regurgitation, while atypical symptoms encompass chest pain, epigastric pain, belching, and extraesophageal symptoms. Epidemiological surveys in China indicate a prevalence of heartburn occurring at least once weekly ranging from 1.9% to 7.0%. Chronic, recurrent GERD significantly impairs patients' quality of life and may increase the risk of Barrett's esophagus, esophageal mucosal dysplasia, and esophageal adenocarcinoma. The etiology of GERD is complex, involving increased esophageal acid exposure, lower esophageal sphincter (LES) relaxation, low esophagogastric junction (EGJ) pressure, impaired esophageal clearance, hiatal hernia, and damage to the mucosal barrier by cytokines (e.g., IL-6, IL-8, platelet-activating factor PAF) and other factors.
Currently, the first-line treatment for GERD includes lifestyle modifications and oral acid-suppressive medications, such as proton pump inhibitors (PPIs) and potassium-competitive acid blockers (P-CABs). However, some patients with refractory GERD require long-term acid-suppressive therapy, and prolonged PPI use may increase the risk of Clostridioides difficile infection, community-acquired pneumonia, gastric cancer, and chronic kidney disease, while short-term P-CAB use may lead to hypergastrinemia [13]. According to the 2020 Chinese GERD Expert Consensus, for patients with refractory GERD who fail medical therapy, endoscopic or surgical treatment may be considered after excluding other causes and confirming evidence of reflux.
Traditional endoscopes are reusable and require cleaning and disinfection after each use, but complete sterilization may not always be achieved, posing a risk of cross-infection. In contrast, disposable endoscopes eliminate the risk of cross-infection, bypass the need for cleaning and disinfection, and reduce the incidence of instrument-related infections, while offering comparable functionality and operability to traditional endoscopes. Endoscopic cardia constriction ligation (ECCL) is an emerging endoscopic treatment technique, first performed by Professor Linghu Enqiang in 2013. This procedure involves ligating and fixing the mucosa and partial muscle layer above the dentate line under direct endoscopic visualization, creating mucosal folds. Post-procedure, the ligated mucosa undergoes ischemic necrosis and heals to form scar tissue, reducing the cardia diameter, increasing LES pressure, and alleviating reflux symptoms. ECCL is characterized by simple operation and minimal invasiveness, making it safer than traditional surgical procedures. Related complications, such as bleeding after ligation band detachment and retrosternal pain, are infrequent, resolve quickly, and no severe adverse events have been reported to date. However, the long-term efficacy of ECCL requires further validation.
Currently, there are no studies on the efficacy and safety of ECCL performed using disposable endoscopes. This study aims to conduct a randomized controlled trial to compare the effectiveness, safety, flexibility, and imaging clarity of ECCL performed with disposable versus traditional endoscopes in treating refractory GERD, providing scientific evidence to optimize treatment strategies and inform future GERD treatment guidelines.
Participants in this study will be randomly assigned to either the disposable endoscope group or the traditional endoscope group to undergo ECCL treatment. The primary objective is to compare the efficacy of ECCL performed with disposable versus traditional endoscopes in treating refractory GERD. Secondary objectives include: 1) Evaluating the observation clarity, flexibility, and compatibility of disposable endoscopes with surgical consumables; 2) Assessing the incidence of device failures and complications related to disposable endoscope-guided ECCL, such as mucosal injury, bleeding, and perforation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: endoscopic cardia constriction ligationThe experimental group will undergo endoscopic cardia constriction ligation (ECCL) using disposable endoscopes. The procedure involves: under direct visualization, sequentially suctioning and ligating one ring each on the lesser curvature, posterior wall, and greater curvature of the cardia, capturing the mucosal and muscular layers. A hemostatic clip will be used to secure the base of the ligated tissue on the greater curvature. Six hours post-procedure, patients may consume lukewarm liquid or semi-liquid diets and continue acid-suppressive therapy for two weeks. Vital signs and any procedure-related serious adverse events will be recorded for statistical analysis. |
| Control Group | Active comparator | Procedure: endoscopic cardia constriction ligationThe control group will undergo endoscopic cardia constriction ligation (ECCL) using traditional endoscopes. The procedure involves: under direct visualization, sequentially suctioning and ligating one ring each on the lesser curvature, posterior wall, and greater curvature of the cardia, capturing the mucosal and muscular layers. A hemostatic clip will be used to secure the base of the ligated tissue on the greater curvature. Six hours post-procedure, patients may consume lukewarm liquid or semi-liquid diets and continue acid-suppressive therapy for two weeks. Vital signs and any procedure-related serious adverse events will be recorded for statistical analysis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (1) Age 18-80 years;
- (2) Disease duration ≥6 months, with typical symptoms such as acid regurgitation and heartburn, and a confirmed diagnosis of GERD;
- (3) GERD patients whose symptoms are not relieved after 8 weeks of continuous double-dose acid-suppressive therapy;
- (4) Willing to participate in the study and have signed the informed consent form.
Key exclusion criteria (6 listed)
- (1) Patients with precancerous lesions such as early esophageal cancer or Barrett's esophagus >3 cm, or advanced upper gastrointestinal cancer identified on endoscopy;
- (2) Patients with hiatal hernia ≥2 cm, severe reflux esophagitis (LA-C or LA-D grade), esophageal or gastric varices, esophageal ulcer or stenosis, or a history of esophageal or gastric surgery;
- (3) Patients with esophageal motility disorders such as achalasia or diffuse esophageal spasm, rheumatic diseases such as systemic sclerosis or Sjögren's syndrome, or eosinophilic esophagitis;
- (4) Patients with a history of endoscopic or surgical anti-reflux procedures;
- (5) Patients with coagulation disorders, severe cardiopulmonary diseases, or inability to tolerate anesthesia, endoscopy, or treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic cardia constriction ligationThe experimental group used disposable endoscopes to perform ECCL, while the control group used traditional endoscopes to perform ECCL. ECCL involves ligating and fixing the mucosa and partial muscle layer above the dentate line under direct endoscopic visualization to create folds. Post-procedure, the ligated mucosa undergoes ischemic necrosis and heals to form scar tissue, thereby reducing the cardia diameter, increasing LES pressure, and alleviating reflux symptoms. | Procedure or surgery | Control Group, Experimental Group |
Primary outcome
Change in GERD-Q Score
Time frame: From baseline before the procedure to 6 months post-procedure
Change in GERD-Q score (a validated questionnaire assessing GERD-related symptoms such as acid regurgitation and heartburn) from baseline, measured in patients undergoing ECCL with disposable endoscopes versus traditional endoscopes. GERD-Q scores are collected at baseline (pre-procedure via questionnaire and endoscopic examination), 3 months post-procedure, and 6 months post-procedure during follow-up visits.
10 secondary outcomes
Rate of Clinical Feasibility of ECCL Treatment Using Disposable Endoscopes
Time frame: From baseline before the procedure to 6 months post-procedure
Device Failure/Defect Rate
Time frame: From baseline before the procedure to 6 months post-procedure
Number of Participants with Endoscope-Related Mucosal Injury
Time frame: From baseline before the procedure to 1 hour post-procedure
Number of Participants with Gastrointestinal Perforation
Time frame: From baseline before the procedure to 1 hour post-procedure
Number of Participants with Significant Bleeding
Time frame: From baseline before the procedure to 1 hour post-procedure
Number of Participants with Procedure-Related Adverse Reactions
Time frame: From baseline before the procedure to 6 months post-procedure
Number of Participants With Clear Endoscopic Image Quality During ECCL Procedure
Time frame: Time Frame: From baseline before the procedure to end of procedure
Number of Participants With Satisfactory Endoscope Flexibility During ECCL Procedure
Time frame: Time Frame: From baseline before the procedure to end of procedure
Number of Participants With Compatible Consumables During ECCL Procedure
Time frame: From baseline before the procedure to end of procedure
Composite Success Rate of ECCL Using Disposable Endoscopes
Time frame: From baseline before the procedure to 6 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Derived from this study: PubMed 42422819Li RH, Yang YY, Xu W, Xia GL, Cheng Q, Cui XB, Zhu Y, Bao XH. Efficacy and safety of endoscopic cardia constriction ligation with a single-use endoscope versus a reusable endoscope for refractory gastroesophageal reflux disease: protocol for a multicenter randomized controlled trial. Front Med (Lausanne). 2026 Jun 24;13:1832310. doi: 10.3389/fmed.2026.1832310. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic cardia constriction ligation in people with Gastroesophageal Reflux Disease (GERD), run by Ying Zhu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Zhu (+86-13384662039, zhuying1@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GERD-Q Score (time frame: From baseline before the procedure to 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07176221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.