GERDPhase 3STRETTAGERDNCT02935881
STRETTA ,Radio Frequency Ablation (RFA) v/s Sham Therapy for the Treatment of Refractory GERD
A Phase 3 study testing Radio Frequency Ablation (RFA) (Stretta Procedure) in people with GERD, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- GERD
- What is being tested?
- Radio Frequency Ablation (RFA) (Stretta Procedure)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2015to Jan 2017
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18years
- Small hiatus hernia (< 2-3 cm)
- Los Angeles Grade 'A' or 'B' Reflux Esophagitis
- LES pressure : 5 - 15 mm Hg
- PPI dependent / refractory GERD
- 24 hr acid exposure study showing abnormal esophageal acid exposure > 4%
- DeMeester Score >14.7
- Esophageal manometry showing normal peristalsis
Who cannot join
- Age < 18 years
- Large hiatus hernia (> 3 cm)
- Los Angeles Grade 'C' or 'D' Reflux Esophagitis
- LES pressure : < 5 or > 15 mm Hg
- Underlying coagulation disorder
- Previous Esophageal or Gastric surgery
- H/o coronary artery disease (CAD)
- Esophageal manometry showing ineffective peristalsis
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Asian insititute of gastroenterology somajiguda, hyderabad india
Hyderabad, Telangana, 500082
Kalapala Dr Rakesh, consultant, 9989211034 ext. 040-23378482, drkalapala@gmail.com
About this study
Official title: A Prospective Randomized Trial Comparing Endoscopic Radio Frequency Ablation (RFA) - STRETTA vs Sham Therapy for the Treatment of Refractory Gastroesophageal Reflux Disease
Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients with reflux disease becoming asymptomatic while taking PPIs. Several studies have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators propose to perform a sham-controlled randomized study to evaluate the influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.
Read the detailed description
Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients with reflux disease becoming asymptomatic while taking PPIs. However, the treatment of patients with proven GERD, who have an unsatisfactory response to high doses of PPIs remains a challenge. A number of endoscopic procedures, aimed at improvement of the barrier function of the lower esophageal sphincter (LES), have emerged over the last decade. Several studies have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators propose to perform a sham-controlled randomized study to evaluate the influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.
- Conditions
- GERD
- Being tested
- Radio Frequency Ablation (RFA) (Stretta Procedure), Sham Procedure
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio Frequency Ablation (RFA) (Stretta Procedure)Device
Radio Frequency Ablation (RFA) for the treatment of refractory gastroesophageal reflux disease.
Sham ProcedureProcedure or surgery
Stretta device will be used but Radio Frequency Ablation (RFA) will not be generated.
| Study group | Role | What they receive |
|---|---|---|
| RFA (Stretta Procedure) | Active comparator | Radio Frequency Ablation (RFA) using a Stretta device. Receives: Device: Radio Frequency Ablation (RFA) (Stretta Procedure) |
| Placebo Arm | Sham comparator | Stretta device used but RFA will not be generated. Receives: Procedure: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who report improvement in Quality of Life (QOL) post Stretta procedure as compared to Sham therapy.
6 point GERD Likert Scale will be used to assess the improvement in frequency and severity of GERD symptoms post Stretta procedure \& Sham therapy amongst patients.
Measured: 1 year
Secondary outcomes (2)
Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta procedure as compared to Sham therapy.
Questionnaire will be provided to each participant to report no further requirement of PPI drug post procedure.
Measured: 1 year
Comparison of Increased Lower Esophageal Sphincter pressure among patients post Stretta procedure & Sham Therapy.
High Resolution Esophageal Manometry will be performed after the procedure in each patient to compare the LES pressure between the two groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
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
- Kalapala Rakesh, MD,DM, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935881
- Sponsor's protocol ID
- aigstretta 001
- Acronym
- STRETTAGERD
- Status last verified
- Oct 2016
- First submitted
- 11 Oct 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Endoscopic Radio Frequency Ablation (RFA) - STRETTA vs Sham Therapy for the Treatment of Refractory Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT02935881
- Acronym / sponsor ID
- STRETTAGERD / aigstretta 001
- Conditions
- GERD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 18 Oct 2016 (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.
Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients with reflux disease becoming asymptomatic while taking PPIs. Several studies have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators propose to perform a sham-controlled randomized study to evaluate the influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.
Detailed description
Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients with reflux disease becoming asymptomatic while taking PPIs. However, the treatment of patients with proven GERD, who have an unsatisfactory response to high doses of PPIs remains a challenge. A number of endoscopic procedures, aimed at improvement of the barrier function of the lower esophageal sphincter (LES), have emerged over the last decade. Several studies have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators propose to perform a sham-controlled randomized study to evaluate the influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA (Stretta Procedure) | Active comparator | Device: Radio Frequency Ablation (RFA) (Stretta Procedure)Radio Frequency Ablation (RFA) using a Stretta device. |
| Placebo Arm | Sham comparator | Procedure: Sham ProcedureStretta device used but RFA will not be generated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18years
- Small hiatus hernia (< 2-3 cm)
- Los Angeles Grade 'A' or 'B' Reflux Esophagitis
- LES pressure : 5 - 15 mm Hg
- PPI dependent / refractory GERD
Key exclusion criteria (8 listed)
- Age < 18 years
- Large hiatus hernia (> 3 cm)
- Los Angeles Grade 'C' or 'D' Reflux Esophagitis
- LES pressure : < 5 or > 15 mm Hg
- Underlying coagulation disorder
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 |
|---|---|---|
| Radio Frequency Ablation (RFA) (Stretta Procedure)Radio Frequency Ablation (RFA) for the treatment of refractory gastroesophageal reflux disease. | Device | RFA (Stretta Procedure) |
| Sham ProcedureStretta device will be used but Radio Frequency Ablation (RFA) will not be generated. | Procedure or surgery | Placebo Arm |
Primary outcome
Number of patients who report improvement in Quality of Life (QOL) post Stretta procedure as compared to Sham therapy.
Time frame: 1 year
6 point GERD Likert Scale will be used to assess the improvement in frequency and severity of GERD symptoms post Stretta procedure \& Sham therapy amongst patients.
2 secondary outcomes
Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta procedure as compared to Sham therapy.
Time frame: 1 year
Comparison of Increased Lower Esophageal Sphincter pressure among patients post Stretta procedure & Sham Therapy.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- 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.
Asian insititute of gastroenterology somajiguda, hyderabad india
Hyderabad, India
Kalapala Rakesh, MD,DM principal investigator
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 Phase 3 study testing Radio Frequency Ablation (RFA) (Stretta Procedure) in people with GERD, 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 8 inclusion and 8 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 18 Oct 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who report improvement in Quality of Life (QOL) post Stretta procedure as compared to Sham therapy. (time frame: 1 year). 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 18 Oct 2016.