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Endoscopic Full Thickness Plication (GERD-X) for the Treatment of PPI Dependent GERD:

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ClinicalTrials.gov Identifier: NCT03322553
Recruitment Status : Not yet recruiting
First Posted : October 26, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Rakesh K, Asian Institute of Gastroenterology, India

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Gastro Esophageal Reflux Disease Device: GERD-X Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double blinded, sham controlled trial
Masking: Double (Participant, Investigator)
Masking Description: Double blinded
Primary Purpose: Treatment
Official Title: Endoscopic Full Thickness Plication (GERD-X) for the Treatment of PPI Dependent GERD: Randomized, Double Blinded, Sham Controlled Trial
Estimated Study Start Date : November 15, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy GERD

Arm Intervention/treatment
Experimental: Plication group
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
Device: GERD-X
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.

Sham Comparator: Sham Group
In sham procedure, identical technique will be followed by positioning the plicator inside the stomach but sutures will not be applied.
Device: GERD-X
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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Improvement in GERD overall symptom and quality of life score [ Time Frame: 12 months ]

    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.


  2. Improvement in GERD symptom sub-score [ Time Frame: 12 months ]

    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.


  3. Requirement of PPI [ Time Frame: 12 months ]

    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


  4. Improvement in oesophageal acidification [ Time Frame: 3 months ]

    Improvement in oesophageal acid exposure at 3 months

    pH more than 4 of more than 4.2%


  5. Improvement in lower oesophageal sphincter pressure [ Time Frame: 3 months ]

    Improvement in lower oesophageal sphincter pressure at 3 months

    Lower Esophageal Sphincter pressure > 15 mm Hg




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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Esophageal dysmotility
  • ASA physical status >II
  • Previous esophageal or gastric surgery
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322553


Contacts
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Contact: Dr. Rakesh Kalapala, MBBS 04023378888 ext 482 drkalpala@gmail.com
Contact: Dr.Arun Karyampudi, MBBS 04023378888 drarunkp87@gmail.com

Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
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Study Director: Dr. D. Nageshwar Reddy, MBBS Asian Institute of Gastroenterology

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Responsible Party: Rakesh K, Principal Investigator, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT03322553     History of Changes
Other Study ID Numbers: GERDX01
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases