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Evaluation of Safety and Effectiveness of the RefluxStop Device in the Management of GERD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02759094
Recruitment Status : Unknown
Verified June 2017 by Implantica CE & Production Ltd.
Recruitment status was:  Recruiting
First Posted : May 3, 2016
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Implantica CE & Production Ltd

Brief Summary:

Prospective, open-label, multi-centre, single arm treatment only trial to evaluate the safety and effectiveness of RefluxStop for the treatment of GERD.

The used medical device "RefluxStop" is an implantable single use sterile device to ensure maintenance of gastro oesophageal junction (GEJ) in an intra-abdominal position to reduce or eliminate GERD.


Condition or disease Intervention/treatment Phase
GERD Device: Treatment with RefluxStop Not Applicable

Detailed Description:

Prospective, open-label, multi-centre, single arm treatment only trial to evaluate the safety and effectiveness of RefluxStop for the treatment of GERD.

The used medical device "RefluxStop" is an implantable single use sterile device to ensure maintenance of gastro oesophageal junction (GEJ) in an intra-abdominal position to reduce or eliminate GERD.

The study plan will include a screening/baseline visit, a surgical procedure phase with hospital stay until discharge, and follow-up visits at 6 weeks, 3 months and 6 months after device implantation.

The study will include a part A (20 patients followed for 6 weeks) and a part B (the first 20 patients assessed at 3 months and 6 months, and the remaining 30 patients assessed at weeks, 3 months, and 6 months).

An independent Safety Monitoring Board (SMB) will review the results of the first 20 patients after 6 weeks.

The Board will also meet one month prior to the anticipated inclusion of 50 patients in order to recommend whether an increase of the sample size will be needed for safety documentation purposes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Effectiveness of the RefluxStop Device in the Management of Gastroesophageal Reflux Disease (GERD)
Actual Study Start Date : December 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : February 2018

Arm Intervention/treatment
Experimental: Treatment with RefluxStop device
A standard laparoscopic approach will be used to reposition the lower oesophageal sphincter (LES) to its intra-abdominal position. The RefluxStop device will be then positioned and fixed in the gastric funds to ensure intra-abdominal positioning of the GEJ at all time
Device: Treatment with RefluxStop
A standard laparoscopic approach will be used to reposition the lower oesophageal sphincter (LES) to its intra-abdominal position. The RefluxStop device will be then positioned and fixed in the gastric funds to ensure intra-abdominal positioning of the GEJ (Gastro-oesophageal Junction) at all time. After confirming proper placement, the laparoscopic implant procedure will be completed and access points will be closed.




Primary Outcome Measures :
  1. Assessment of incidence of serious adverse device effects (SADEs) and procedure-related serious adverse events (SAEs) [ Time Frame: through study completion, up to 6 months ]
  2. Assessment of percent reduction from baseline of GERD symptoms based on the GERD-HRQL score (questions 1-10) measured after the procedure [ Time Frame: Change from Baseline GERD symptoms to 6 months ]
    Efficacy endpoint


Secondary Outcome Measures :
  1. Assessment of incidence of adverse device effects (ADEs) and procedure-related adverse events (AEs) [ Time Frame: through study completion, up to 6 months ]
  2. Assessment of reduction from baseline of GERD symptoms based on the GERD-HRQL score (questions 1-10) measured after the procedure [ Time Frame: Change from Baseline GERD symptoms to 6 months ]
    Efficacy endpoint

  3. Assessment of reduction or normalisation from baseline of the total acid (pH<4) exposure time on 24-hour pH monitoring [ Time Frame: Baseline, 3 months FUP ]
    Efficacy endpoint

  4. Assessment of reduction from baseline in average daily PPI dosage after the procedure [ Time Frame: through study completion, up to 6 months ]
    Efficacy endpoint

  5. Assessment of reduction from baseline of foregut questionnaire scores after the procedure [ Time Frame: through study completion, up to 6 months ]
    Efficacy endpoint

  6. Assessment of improvement in oesophagitis on upper endoscopy [ Time Frame: Baseline, 3 months FUP ]
  7. Assessment of effectiveness of the device by a barium swallow examination [ Time Frame: Baseline, 6 weeks FUP, 6 months FUP ]
  8. Assessment of effectiveness (location and function) of the device by X-ray [ Time Frame: Baseline and after Implantation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject's age >= 18 years and <= 75 years
  • Subject is able to undergo general anaesthesia and is a suitable laparoscopic surgical candidate
  • Subject is willing and able to participate
  • Subject has provided written informed consent after being informed of the study procedure and risks prior to any study-related events
  • Subject has documented typical GERD symptoms present for > 6 months which respond to PPIs as anti-GERD medication. Typical symptom of GERD is defined as heartburn, which is a burning epigastric or substernal pain
  • Subject requires daily PPI anti GERD medication
  • Subject has a 24-hour pH monitoring proven GERD performed taken off any anti reflux medication or after discontinuation for at least 7 days prior to testing. Total distal oesophageal pH must be <= 4 for >= 4.5% if time during a 24-hour monitoring

Exclusion Criteria:

  • Subject is currently participating in another study involving investigational drugs or devices
  • Subject has a history of gastro oesophageal surgery, anti-reflux or bariatric procedure
  • Subject has a history of endoscopic anti-reflux intervention
  • Subject has a history or a suspicion of oesophageal or gastric cancer
  • Subject has a history of major psychiatric disorder
  • Presence of a para-oesophageal hernia or sliding hernia of > 3cm determined on endoscopy
  • Presence of an oesophagitis grade C or D according to the Los Angeles classification
  • Presence of oesophageal dysmotility disorder such as but not limited to sclerodermia, achalasia, Nutcracker oesophagus
  • Presence of oesophageal stricture or stenosis
  • Presence of delayed gastric emptying
  • Presence of oesophageal or gastric varies
  • Subject has a body mass index (BMI) > 35kg/m2
  • Female patients who are pregnant or nursing
  • Subjects who are unable to comply with the protocol requirements
  • Subjects with limited life expectancy (< 3 years)
  • Intra-operative findings that may preclude conduct of the study procedures

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): NCT02759094


Contacts
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Contact: Stephan Siegenthaler, Dr. +41 79 250 48 60 siegenthaler@implantica.com

Locations
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Hungary
Semmelweis University Recruiting
Budapest, Hungary, 1082
Contact: László Harsányi, prof    +36 1 333 5343    harsanyi.laszlo@med.semmelweis-univ.hu   
Sponsors and Collaborators
Implantica CE & Production Ltd
Investigators
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Principal Investigator: László Harsányi, Prof. Semmelweis University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Implantica CE & Production Ltd
ClinicalTrials.gov Identifier: NCT02759094    
Other Study ID Numbers: RXI 001
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Keywords provided by Implantica CE & Production Ltd:
GERD
Implantable medical device
RefluxStop
Reflux
Gastroesophageal Reflux
Laparoscopy
pH-Monitoring
PPI proton pump inhibitors
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases