Gastroesophageal Reflux DiseaseNCT02500264
The Effect of Non Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD) Symptoms - Proof of Concept Study
A study testing TENS in people with Gastroesophageal Reflux Disease, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The aims of the study: To evaluate whether the use of a specific TENS technology can improve GERD symptoms and esophageal acid exposure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2015to Oct 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 3 episodes of heartburn and/or regurgitation in a week for at least 3 months.
- evidence for an abnormal esophagal acid exposure on impedance-pH monitoring (tested in the last 2 years off PPI)
Who cannot join
- gastric or esophagal surgery
- active peptic ulcer disease
- malignancy
- pregnancy
- uncontrolled diabetes mellitus
- severe cardiac conditions such as cardiac arrhythmia or ischemia or cardiac pacemaker/defibrillator
Show all 9Show fewer
- allergy to adhesives/patches
- severe pulmonary disease
- obesity (BMI>30)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva, 4941492
ram dickman, professor, +97239377235, dickmanr@clalit.org.il
maor pauker, Dr., +97235056708, maorha11@clalit.org.il
About this study
The aims of the study: To evaluate whether the use of a specific TENS technology can improve GERD symptoms and esophageal acid exposure.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- TENS
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
| Study group | Role | What they receive |
|---|---|---|
| Protocol #1 | Active comparator | interventions: 1.6Hz, Rampdown 0.4S, electrodes position - both L.Rectus Abdominis, 5cmX5cm Size, on inspirium Receives: Device: TENS |
| Protocol #2 | Active comparator | 1Hz, Rampdown 0.6S, electrodes position - both Rectus Abdominis, 5cmX5cm Size, on inspirium Receives: Device: TENS |
| Protocol #3 | Active comparator | 1.6Hz, Rampdown 0.4S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium Oblique Receives: Device: TENS |
| Protocol #4 | Active comparator | 1Hz, Rampdown 0.6S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment
Measured: 34 days
Secondary outcomes (1)
Esophageal acid exposure before and after treatment
Ph monitoring
Measured: 34 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ram Dickman, Rabin Medical Center
- Investigators
- ram dickman, professor, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500264
- Sponsor's protocol ID
- 0293-15-RMC
- Status last verified
- Sep 2017
- First submitted
- 1 Jul 2015
- Last updated
- 20 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD) Symptoms - Proof of Concept Study
- ClinicalTrials.gov ID
- NCT02500264
- Acronym / sponsor ID
- 0293-15-RMC
- Conditions
- Gastroesophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 16 Jul 2015 (estimated)
- 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.
The aims of the study: To evaluate whether the use of a specific TENS technology can improve GERD symptoms and esophageal acid exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Protocol #1 | Active comparator | Device: TENSinterventions: 1.6Hz, Rampdown 0.4S, electrodes position - both L.Rectus Abdominis, 5cmX5cm Size, on inspirium |
| Protocol #2 | Active comparator | Device: TENS1Hz, Rampdown 0.6S, electrodes position - both Rectus Abdominis, 5cmX5cm Size, on inspirium |
| Protocol #3 | Active comparator | Device: TENS1.6Hz, Rampdown 0.4S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium Oblique |
| Protocol #4 | Active comparator | Device: TENS1Hz, Rampdown 0.6S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 3 episodes of heartburn and/or regurgitation in a week for at least 3 months.
- evidence for an abnormal esophagal acid exposure on impedance-pH monitoring (tested in the last 2 years off PPI)
Key exclusion criteria (9 listed)
- gastric or esophagal surgery
- active peptic ulcer disease
- malignancy
- pregnancy
- uncontrolled diabetes mellitus
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 |
|---|---|---|
| TENS | Device | Protocol #1, Protocol #2, Protocol #3, Protocol #4 |
Primary outcome
Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment
Time frame: 34 days
1 secondary outcome
Esophageal acid exposure before and after treatment
Time frame: 34 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
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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.
ram dickman, professor principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Gastroesophageal Reflux Disease, run by Rabin Medical Center at 1 site in Israel.
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 9 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: status not confirmed, as of the sponsor's last update on 20 Sep 2017. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ram dickman, professor (+97239377235, dickmanr@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment (time frame: 34 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2017.