Gastro Esophageal Reflux DiseaseNCT03322553
Endoscopic Full Thickness Plication (GERD-X) for the Treatment of PPI Dependent GERD:
A study testing GERD-X in people with Gastro Esophageal Reflux Disease, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Gastro-esophageal reflux disease (GERD) is a common gastrointestinal disorder with a significant proportion of patients becoming dependent on proton pump inhibitor (PPI) therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastro Esophageal Reflux Disease
- What is being tested?
- GERD-X
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- 15 Nov 2017to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal pH less than 4 of more than 4.2% on pH-metry during 24-h period while off PPI
- Patients who are willing to pay the expenses of the GERD-X procedure
Who cannot join
- Large Hiatal hernia >3cm
- Gr C/D esophagitis
- Lower esophageal sphincter (LES) pressure <5 or >15 mm Hg
- Paraesophageal hernia
- GE flap valve grade IV (Hill's classification)
- Barretts esophagus
Show all 10Show fewer
- Esophageal dysmotility
- ASA physical status >II
- Previous esophageal or gastric surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Full Thickness Plication (GERD-X) for the Treatment of PPI Dependent GERD: Randomized, Double Blinded, Sham Controlled Trial
Gastro-esophageal reflux disease (GERD) is a common gastrointestinal disorder with a significant proportion of patients becoming dependent on proton pump inhibitor (PPI) therapy. Long term use of PPI therapy can be associated with side effects such as osteoporosis, small intestinal bacterial overgrowth and renal failure. Moreover, some of the patients might be reluctant to take PPIs for long duration and prefer surgery over pharmacotherapy. Endoscopic plication (GERD-X) is an alternative and less invasive procedure compared to laparoscopic fundoplication for the treatment of GERD. In endoscopic plication, transmural sutures are applied at the gastro-esophageal (GE) junction thereby reconstructing the gastric cardia and accentuating the valvular mechanism to prevent reflux. Only few trials have evaluated the efficacy of endoscopic plication technique and reported encouraging results. In this study we aim to evaluate the efficacy of a similar endoscopic technique but with application of two transmural sutures in randomized controlled method.
Read the detailed description
Patients screening and inclusion:
The study will be conducted over 6-month period. Data of patients presenting with PPI dependent GERD will be recorded and maintained. At initial screening, GERD health related quality of life questionnaire (GERD HRQL) and requirement of anti-secretory medicines (detailed drug history) will be assessed along with gastroscopy. All anti-secretory medicines will be stopped for 7 days and GERD HRQL will be reassessed off drugs. Esophageal high resolution manometry with 24-h pH impedance monitoring will be done on the 8th day after stopping medicines. Basal lower esophageal sphincter (LES) pressure, esophageal motility pattern, 24-h esophageal acid exposure, non acidic bolus reflux, number of reflux episodes, DeMeester score, symptom index and symptom association probability would be assessed. Those patients with pathologic esophageal acid exposure (esophageal pH <4 for >4.2% of 24-h period) will be included in the trial. Patients will then be randomly assigned by a computer to either GERD-X or sham procedure with a target ratio of 1:1. The patient, principle investigator and the study coordinators would be blinded to the treatment assignment.
Intervention:
In patients allocated to endoscopic plication, endoscopic full-thickness plication will be performed using the GERDX® system. All procedures will be performed under general anesthesia. Savary-guidewire will be placed into the stomach using a gastroscope. The GERDX® system will be introduced over the guidewire and into the stomach. The subsequent procedure will be performed as described in previous studies, using a similar device (NDO Plicator). According to study protocol, at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of GE junction around the endoscope. In sham procedure, identical technique will be followed by positioning the plicator 1cm below the GE junction but sutures will not be deployed.
Post intervention monitoring:
Immediately after the intervention, patients would be placed on soft diet and on demand analgesics for 5 days. Twice daily PPI will be given for all patients and would be stopped after 7 days. Thereafter, if patient experiences reflux symptoms, sucralfate, H2 blocker and PPI would be started sequentially in case of no response to the former drug after a period of 7days of therapy on each drug. Requirement and reintroduction of drugs will be enquired over phone and recorded appropriately.
Follow up:
Follow up visits will be carried out at 3, 6 and 12 months. During each visit, gastroscopy will be done to assess the gastro-esophageal junction along with evaluation of GERD HRQL and requirement of PPI. At 3 months post intervention, esophageal manometry and 24-h pH impedance monitoring would be performed.
Primary outcomes:
Improvement in GERD HRQL by more than 50% from baseline at 3 months
Secondary outcomes:
Improvement in GERD HRQL at 3, 6 and 12 months Improvement in symptom score and requirement of PPI at 3, 6 and 12 months Improvement in esophageal acid exposure and lower esophageal sphincter pressure at 3 months
Statistical Analysis The trial was designed to have a 90% power to detect a difference in GERD-HRQL post intervention at 5% level of significance.
The rate of improvement in GERD-HRQL for sham group is 35% and for active group is 70 %. A sample size of 38 is required for each group to achieve a statistical power of 80% at 5% type I error.
Statistical methods Continuous data will be expressed as median and inter-quartile range (IQR). Frequency will be expressed as percentage (%). Continuous and categorical data between active and sham groups will be compared using Mann-Whitney U test and Chi-square test, with Yates' correction as applicable, respectively. P values below 0.05 will be considered significant.
- Conditions
- Gastro Esophageal Reflux Disease
- Being tested
- GERD-X
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GERD-XDevice
Endoscopic full-thickness plication will be performed using the GERDX® system. All procedures will be performed under general anesthesia. Savary-guidewire will be placed into the stomach using a gastroscope. The GERDX® system will be introduced over the guidewire into the stomach and retroflexed. The GE junction will be visualized using another slim endoscope passed through a channel present in the GERD-X device. According to study protocol, at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of gastro-esophageal junction around the GERD-X device.
| Study group | Role | What they receive |
|---|---|---|
| Plication group | Experimental | In patients allocated to endoscopic plication, endoscopic full-thickness plication will be performed using the GERDX® system. All procedures will be performed under general anesthesia. Savary-guidewire will be placed into the stomach using a gastroscope. The GERDX® system will be introduced over the guidewire into the stomach and retroflexed. The GE junction will be visualized using another slim endoscope passed through a channel present in the GERD-X device. According to study protocol, at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of GE junction around the GERD-X device Receives: Device: GERD-X |
| Sham Group | Sham comparator | In sham procedure, identical technique will be followed by positioning the plicator inside the stomach but sutures will not be applied. Receives: Device: GERD-X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in GERD
Improvement in GERD HRQL by more than 50% from baseline at 3 months
GERD - Health Related Quality of Life Questionnaire (GERD-HRQL) :
Total Score: Calculated by summing the individual scores toquestions 1-15 Greatest possible score ( worst symptoms)= 75 Lowest possible score ( no symptoms)= 0
Heartburn Score: Calculated by summing the individual scores to questions 1-6 .
Worst heartburn symptoms = 30 No heartburn symptoms= 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination.
Regurgitation Score: Calculated by summing the individual scores to questions10-15.
Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.
Measured: 3months
Secondary outcomes (5)
Improvement in GERD overall symptom and quality of life score
Improvement in GERD HRQL at 3, 6 and 12 months
GERD - Health Related Quality of Life Questionnaire (GERD-HRQL) :
Total Score: Calculated by summing the individual scores toquestions 1-15 Greatest possible score ( worst symptoms)= 75 Lowest possible score ( no symptoms)= 0
Heartburn Score: Calculated by summing the individual scores to questions 1-6 .
Worst heartburn symptoms = 30 No heartburn symptoms= 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination.
Regurgitation Score: Calculated by summing the individual scores to questions10-15.
Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.
Measured: 12 months
Improvement in GERD symptom sub-score
Improvement in GERD symptom (heartburn and regurgitation) score at 3, 6 and 12 months
GERD - Health Related Quality of Life Questionnaire (GERD-HRQL) :
Total Score: Calculated by summing the individual scores toquestions 1-15 Greatest possible score ( worst symptoms)= 75 Lowest possible score ( no symptoms)= 0
Heartburn Score: Calculated by summing the individual scores to questions 1-6 .
Worst heartburn symptoms = 30 No heartburn symptoms= 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination.
Regurgitation Score: Calculated by summing the individual scores to questions10-15.
Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.
Measured: 12 months
Requirement of PPI
Requirement of PPI for control of symptoms at 3, 6 and 12 months
Heartburn and Regurgitation questionnaire
0 =No symptom
1 =Symptoms noticeablebut not bothersome 2=S ymptoms noticeableand bothersome but noteve ry day 3 =Symptoms bothersome every day 4 =Symptoms affect daily activity 5 =Symptoms are incapacitating to do daily activities
Measured: 12 months
Improvement in oesophageal acidification
Improvement in oesophageal acid exposure at 3 months
pH more than 4 of more than 4.2%
Measured: 3 months
Improvement in lower oesophageal sphincter pressure
Improvement in lower oesophageal sphincter pressure at 3 months
Lower Esophageal Sphincter pressure > 15 mm Hg
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start15 Nov 2017
- Primary completion30 Aug 2019
- Study completion30 Dec 2019
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 Gastro Esophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- 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
- Model description
- Randomized, Double blinded, sham controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rakesh K, Asian Institute of Gastroenterology, India
- Investigators
- Dr. D. Nageshwar Reddy, MBBS, Study director, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322553
- Sponsor's protocol ID
- GERDX01
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2017
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalapala R, Karyampudi A, Nabi Z, Darisetty S, Jagtap N, Ramchandani M, Gupta R, Lakhtakia S, Goud R, Venkat Rao G, Sharma P, Reddy DN. Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial. Gut. 2022 Apr;71(4):686-694. doi: 10.1136/gutjnl-2020-321811. Epub 2021 Apr 13.
PubMed 33849942
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Full Thickness Plication (GERD-X) for the Treatment of PPI Dependent GERD: Randomized, Double Blinded, Sham Controlled Trial
- ClinicalTrials.gov ID
- NCT03322553
- Acronym / sponsor ID
- GERDX01
- Conditions
- Gastro Esophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 26 Oct 2017 (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.
Gastro-esophageal reflux disease (GERD) is a common gastrointestinal disorder with a significant proportion of patients becoming dependent on proton pump inhibitor (PPI) therapy. Long term use of PPI therapy can be associated with side effects such as osteoporosis, small intestinal bacterial overgrowth and renal failure. Moreover, some of the patients might be reluctant to take PPIs for long duration and prefer surgery over pharmacotherapy. Endoscopic plication (GERD-X) is an alternative and less invasive procedure compared to laparoscopic fundoplication for the treatment of GERD. In endoscopic plication, transmural sutures are applied at the gastro-esophageal (GE) junction thereby reconstructing the gastric cardia and accentuating the valvular mechanism to prevent reflux. Only few trials have evaluated the efficacy of endoscopic plication technique and reported encouraging results. In this study we aim to evaluate the efficacy of a similar endoscopic technique but with application of two transmural sutures in randomized controlled method.
Detailed description
Patients screening and inclusion:
The study will be conducted over 6-month period. Data of patients presenting with PPI dependent GERD will be recorded and maintained. At initial screening, GERD health related quality of life questionnaire (GERD HRQL) and requirement of anti-secretory medicines (detailed drug history) will be assessed along with gastroscopy. All anti-secretory medicines will be stopped for 7 days and GERD HRQL will be reassessed off drugs. Esophageal high resolution manometry with 24-h pH impedance monitoring will be done on the 8th day after stopping medicines. Basal lower esophageal sphincter (LES) pressure, esophageal motility pattern, 24-h esophageal acid exposure, non acidic bolus reflux, number of reflux episodes, DeMeester score, symptom index and symptom association probability would be assessed. Those patients with pathologic esophageal acid exposure (esophageal pH <4 for >4.2% of 24-h period) will be included in the trial. Patients will then be randomly assigned by a computer to either GERD-X or sham procedure with a target ratio of 1:1. The patient, principle investigator and the study coordinators would be blinded to the treatment assignment.
Intervention:
In patients allocated to endoscopic plication, endoscopic full-thickness plication will be performed using the GERDX® system. All procedures will be performed under general anesthesia. Savary-guidewire will be placed into the stomach using a gastroscope. The GERDX® system will be introduced over the guidewire and into the stomach. The subsequent procedure will be performed as described in previous studies, using a similar device (NDO Plicator). According to study protocol, at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of GE junction around the endoscope. In sham procedure, identical technique will be followed by positioning the plicator 1cm below the GE junction but sutures will not be deployed.
Post intervention monitoring:
Immediately after the intervention, patients would be placed on soft diet and on demand analgesics for 5 days. Twice daily PPI will be given for all patients and would be stopped after 7 days. Thereafter, if patient experiences reflux symptoms, sucralfate, H2 blocker and PPI would be started sequentially in case of no response to the former drug after a period of 7days of therapy on each drug. Requirement and reintroduction of drugs will be enquired over phone and recorded appropriately.
Follow up:
Follow up visits will be carried out at 3, 6 and 12 months. During each visit, gastroscopy will be done to assess the gastro-esophageal junction along with evaluation of GERD HRQL and requirement of PPI. At 3 months post intervention, esophageal manometry and 24-h pH impedance monitoring would be performed.
Primary outcomes:
Improvement in GERD HRQL by more than 50% from baseline at 3 months
Secondary outcomes:
Improvement in GERD HRQL at 3, 6 and 12 months Improvement in symptom score and requirement of PPI at 3, 6 and 12 months Improvement in esophageal acid exposure and lower esophageal sphincter pressure at 3 months
Statistical Analysis The trial was designed to have a 90% power to detect a difference in GERD-HRQL post intervention at 5% level of significance.
The rate of improvement in GERD-HRQL for sham group is 35% and for active group is 70 %. A sample size of 38 is required for each group to achieve a statistical power of 80% at 5% type I error.
Statistical methods Continuous data will be expressed as median and inter-quartile range (IQR). Frequency will be expressed as percentage (%). Continuous and categorical data between active and sham groups will be compared using Mann-Whitney U test and Chi-square test, with Yates' correction as applicable, respectively. P values below 0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, Double blinded, sham controlled trial
| Arm | Type | Receives |
|---|---|---|
| Plication group | Experimental | Device: GERD-XIn patients allocated to endoscopic plication, endoscopic full-thickness plication will be performed using the GERDX® system. All procedures will be performed under general anesthesia. Savary-guidewire will be placed into the stomach using a gastroscope. The GERDX® system will be introduced over the guidewire into the stomach and retroflexed. The GE junction will be visualized using another slim endoscope passed through a channel present in the GERD-X device. According to study protocol, at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of GE junction around the GERD-X device |
| Sham Group | Sham comparator | Device: GERD-XIn sham procedure, identical technique will be followed by positioning the plicator inside the stomach but sutures will not be applied. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal pH less than 4 of more than 4.2% on pH-metry during 24-h period while off PPI
- Patients who are willing to pay the expenses of the GERD-X procedure
Key exclusion criteria (10 listed)
- Large Hiatal hernia >3cm
- Gr C/D esophagitis
- Lower esophageal sphincter (LES) pressure <5 or >15 mm Hg
- Paraesophageal hernia
- GE flap valve grade IV (Hill's classification)
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 |
|---|---|---|
| GERD-XEndoscopic full-thickness plication will be performed using the GERDX® system. All procedures will be performed under general anesthesia. Savary-guidewire will be placed into the stomach using a gastroscope. The GERDX® system will be introduced over the guidewire into the stomach and retroflexed. The GE junction will be visualized using another slim endoscope passed through a channel present in the GERD-X device. According to study protocol, at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of gastro-esophageal junction around the GERD-X device. | Device | Plication group, Sham Group |
Primary outcome
Improvement in GERD
Time frame: 3months
Improvement in GERD HRQL by more than 50% from baseline at 3 months GERD - Health Related Quality of Life Questionnaire (GERD-HRQL) : Total Score: Calculated by summing the individual scores toquestions 1-15 Greatest possible score ( worst symptoms)= 75 Lowest possible score ( no symptoms)= 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . Worst heartburn symptoms = 30 No heartburn symptoms= 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.
5 secondary outcomes
Improvement in GERD overall symptom and quality of life score
Time frame: 12 months
Improvement in GERD symptom sub-score
Time frame: 12 months
Requirement of PPI
Time frame: 12 months
Improvement in oesophageal acidification
Time frame: 3 months
Improvement in lower oesophageal sphincter pressure
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Derived from this study: PubMed 33849942Kalapala R, Karyampudi A, Nabi Z, Darisetty S, Jagtap N, Ramchandani M, Gupta R, Lakhtakia S, Goud R, Venkat Rao G, Sharma P, Reddy DN. Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial. Gut. 2022 Apr;71(4):686-694. doi: 10.1136/gutjnl-2020-321811. Epub 2021 Apr 13.
- 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. This study is not recruiting at the moment.
Dr. D. Nageshwar Reddy, MBBS study director
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GERD-X in people with Gastro Esophageal Reflux Disease, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 2 inclusion and 10 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: finished, as of the sponsor's last update on 22 Jan 2020. 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 India. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in GERD (time frame: 3months). 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 NCT03322553, 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 22 Jan 2020.