GERDNECTARNCT03090607
Novel Endoluminal Clinical TreAtment of Reflux
A study testing Aluvra™ and Saline in people with GERD, run by Impleo Medical Inc. at 10 sites in United States.
Trial summary
This is a prospective, multi-center, double-blind, crossover, randomized controlled trial designed to demonstrate the safety and efficacy of Aluvra for the treatment of GERD. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- GERD
- What is being tested?
- Aluvra™ and Saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Nov 2017to Jul 2022
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of heartburn-like pain, regurgitation, or both prior to the initiation of proton pump inhibitor (PPIs) therapy.
- History of GERD symptoms of at least six months despite continuous PPIs.
- GERD-HRQL score ≥15 after discontinuing PPI therapy.
- GERD-HRQL score improvement of at least 6 points while on PPIs, with at least 4-point improvement in heartburn subscore.
- A minimum GERD-HRQL score while on PPIs of 2.
- Pathologic acid exposure time, a baseline pH <4.0 for ≥ 5.3% of time during a 48-hour evaluation period.
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- Twenty two years of age or older.
- Life expectancy of at least two years.
- Willing and able to return to the clinic or hospital for all evaluation procedures scheduled throughout the course of this study.
- Is capable of understanding clinical study procedures and giving informed consent.
Who cannot join
- Unable to tolerate an endoscopic procedure
- Presence of esophageal or gastric varices
- Presence of erosive esophagitis (LA Classification of C or D)
- Presence of a hiatal hernia > 2 cm
- Presence of Barrett's esophagus
- Presence of esophageal motility disorder
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- History of or known esophageal stricture or gross esophageal anatomic abnormalities
- Symptoms of dysphagia more than once per week within the last six months
- Obesity (BMI ≥ 35)
- Gastric or esophageal cancer undergoing active treatment
- Received radiation therapy to the esophagus and has fibrosis of the tissue at the likely injection sites
- Had an ablation procedure in the lower esophageal sphincter area
- Has a condition that could lead to significant postoperative complications, including current infection, anticoagulant use, uncontrolled diabetes or autoimmune disorder
- Enrolled in a concurrent clinical trial
- Inability to comply with study protocol due to a chronic disease, psychiatric illness, alcoholism, drug abuse, or geographic distance (as determined by investigator)
- Pregnant and/or given birth in the previous twelve months or who plan to become pregnant in the next twelve months
- Prior gastric or GERD surgery
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Esophageal Institute of Atlanta
Atlanta, Georgia, 30309
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Northwestern Memorial Hospital
Chicago, Illinois, 60611
SOFI - Center for Esophageal Wellness
Englewood, Colorado, 80113
Mayo Clinic Florida
Jacksonville, Florida, 32224
Keck School of Medicine of USC
Los Angeles, California, 90033
Aurora Medical Center Summit
Milwaukee, Wisconsin, 53066
Digestive Health Center
Palo Alto, California, 94304
The Oregon Clinic, Gastrointestinal and Minimally Invasive Surgery Division
Portland, Oregon, 97213
Washington University in Saint Louis
St Louis, Missouri, 63110
About this study
Official title: A 12-month Double-blind, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Efficacy of Endoluminal Aluvra™ for the Treatment of Gastroesophageal Reflux Disease
This is a prospective, multi-center, double-blind, crossover, randomized controlled trial designed to demonstrate the safety and efficacy of Aluvra for the treatment of GERD.
- Conditions
- GERD
- Being tested
- Aluvra™, Saline
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aluvra™Device
Also called injectable bulking agent for GERD
Endoscopic injection of bulking agent to the lower esophageal sphincter
SalineDrug
Endoscopic injection of saline
| Study group | Role | What they receive |
|---|---|---|
| Aluvra™ | Experimental | Endoscopic injection of bulking agent (Aluvra) to the lower esophageal sphincter Receives: Device: Aluvra™ |
| Saline | Sham comparator | Endoscopic injection of saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Aluvra- GERD HRQL
Efficacy will be established through two co-primary objectives. The first co-primary endpoint will be to compare response rates between treatment group and control group at 12 months based on the GERD-Health Related Quality of Life questionnaire.
Measured: 12 months
Efficacy of Aluvra- Esophageal PH
Efficacy will be established through two co-primary objectives. The second co-primary endpoint will be to compare change from baseline in total percent time esophageal pH <4 between the treatment group vs. the sham control group at 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start1 Nov 2017
- Primary completionJul 2021 (estimated)
- Study completionJul 2022 (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.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Impleo Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090607
- Sponsor's protocol ID
- NECTAR
- Acronym
- NECTAR
- Status last verified
- Mar 2020
- First submitted
- 15 Mar 2017
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month Double-blind, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Efficacy of Endoluminal Aluvra™ for the Treatment of Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT03090607
- Acronym / sponsor ID
- NECTAR / NECTAR
- Conditions
- GERD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Impleo Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 27 Mar 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.
This is a prospective, multi-center, double-blind, crossover, randomized controlled trial designed to demonstrate the safety and efficacy of Aluvra for the treatment of GERD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aluvra™ | Experimental | Device: Aluvra™Endoscopic injection of bulking agent (Aluvra) to the lower esophageal sphincter |
| Saline | Sham comparator | Drug: SalineEndoscopic injection of saline |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- History of heartburn-like pain, regurgitation, or both prior to the initiation of proton pump inhibitor (PPIs) therapy.
- History of GERD symptoms of at least six months despite continuous PPIs.
- GERD-HRQL score ≥15 after discontinuing PPI therapy.
- GERD-HRQL score improvement of at least 6 points while on PPIs, with at least 4-point improvement in heartburn subscore.
- A minimum GERD-HRQL score while on PPIs of 2.
Key exclusion criteria (17 listed)
- Unable to tolerate an endoscopic procedure
- Presence of esophageal or gastric varices
- Presence of erosive esophagitis (LA Classification of C or D)
- Presence of a hiatal hernia > 2 cm
- Presence of Barrett's esophagus
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 |
|---|---|---|
| Aluvra™Also: injectable bulking agent for GERDEndoscopic injection of bulking agent to the lower esophageal sphincter | Device | Aluvra™ |
| SalineEndoscopic injection of saline | Drug | Saline |
Primary outcome
Efficacy of Aluvra- GERD HRQL
Time frame: 12 months
Efficacy will be established through two co-primary objectives. The first co-primary endpoint will be to compare response rates between treatment group and control group at 12 months based on the GERD-Health Related Quality of Life questionnaire.
Efficacy of Aluvra- Esophageal PH
Time frame: 12 months
Efficacy will be established through two co-primary objectives. The second co-primary endpoint will be to compare change from baseline in total percent time esophageal pH <4 between the treatment group vs. the sham control group at 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aluvra™ and Saline in people with GERD, run by Impleo Medical Inc. at 10 sites in United States.
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 10 inclusion and 17 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 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Results are not available in the source record.
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?
Efficacy of Aluvra- GERD HRQL (time frame: 12 months). The study lists 2 primary outcomes in all. 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 12 Mar 2020.