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Novel Endoluminal Clinical TreAtment of Reflux (NECTAR)

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ClinicalTrials.gov Identifier: NCT03090607
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Impleo Medical Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
GERD Device: Aluvra™ Drug: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Aluvra™
Endoscopic injection of bulking agent (Aluvra) to the lower esophageal sphincter
Device: Aluvra™
Endoscopic injection of bulking agent to the lower esophageal sphincter
Other Name: injectable bulking agent for GERD

Sham Comparator: Saline
Endoscopic injection of saline
Drug: Saline
Endoscopic injection of saline




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. History of heartburn-like pain, regurgitation, or both prior to the initiation of proton pump inhibitor (PPIs) therapy.
  2. History of GERD symptoms of at least six months despite continuous PPIs.
  3. GERD-HRQL score ≥15 after discontinuing PPI therapy.
  4. GERD-HRQL score improvement of at least 6 points while on PPIs, with at least 4-point improvement in heartburn subscore.
  5. A minimum GERD-HRQL score while on PPIs of 2.
  6. Pathologic acid exposure time, a baseline pH <4.0 for ≥ 5.3% of time during a 48-hour evaluation period.
  7. Twenty two years of age or older.
  8. Life expectancy of at least two years.
  9. Willing and able to return to the clinic or hospital for all evaluation procedures scheduled throughout the course of this study.
  10. Is capable of understanding clinical study procedures and giving informed consent.

Exclusion Criteria:

  1. Unable to tolerate an endoscopic procedure
  2. Presence of esophageal or gastric varices
  3. Presence of erosive esophagitis (LA Classification of C or D)
  4. Presence of a hiatal hernia > 2 cm
  5. Presence of Barrett's esophagus
  6. Presence of esophageal motility disorder
  7. History of or known esophageal stricture or gross esophageal anatomic abnormalities
  8. Symptoms of dysphagia more than once per week within the last six months
  9. Obesity (BMI ≥ 35)
  10. Gastric or esophageal cancer undergoing active treatment
  11. Received radiation therapy to the esophagus and has fibrosis of the tissue at the likely injection sites
  12. Had an ablation procedure in the lower esophageal sphincter area
  13. Has a condition that could lead to significant postoperative complications, including current infection, anticoagulant use, uncontrolled diabetes or autoimmune disorder
  14. Enrolled in a concurrent clinical trial
  15. Inability to comply with study protocol due to a chronic disease, psychiatric illness, alcoholism, drug abuse, or geographic distance (as determined by investigator)
  16. Pregnant and/or given birth in the previous twelve months or who plan to become pregnant in the next twelve months
  17. Prior gastric or GERD surgery

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): NCT03090607


Contacts
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Contact: sharona segal-leibovich 6128453667 ssegal@impleomedical.com
Contact: Juliana Elstad jelstad@impleomedical.com

Locations
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United States, California
Keck School of Medicine of USC Recruiting
Los Angeles, California, United States, 90033
Contact: Michelle Hernandez    323-442-6252    Michelle.Hernandez@med.usc.edu   
Principal Investigator: John Lipham, MD         
Digestive Health Center Recruiting
Palo Alto, California, United States, 94304
Contact: Divya Pathak    650-721-8437    Divya22@stanford.edu   
Principal Investigator: John Clarke, MD         
United States, Colorado
SOFI - Center for Esophageal Wellness Recruiting
Englewood, Colorado, United States, 80113
Contact: Rachel Heidrick    303-788-1636    rachel@sofisite.com   
Principal Investigator: Reginald Bell, MD         
United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Natalie Fares       Fares.Natalie@Mayo.edu   
Principal Investigator: Brian Lacy, MD         
United States, Georgia
Esophageal Institute of Atlanta Recruiting
Atlanta, Georgia, United States, 30309
Contact: Terria Nesmith    404-445-7787    research@esophageal.institute   
Principal Investigator: Daniel Smith, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Melina Masihi    312-695-0330    melina.masihi@northwestern.edu   
Principal Investigator: John Pandolfino, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Maria Hofbauer,    617-677-4046    mhofbaue@bidmc.harvard.edu   
Principal Investigator: Douglas Pleskow, MD         
United States, Missouri
Washington University in Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Darren Nix    314-362-3201    nixd@wustl.edu   
Principal Investigator: Prakash C Gyawali, MD         
United States, Oregon
The Oregon Clinic, Gastrointestinal and Minimally Invasive Surgery Division Recruiting
Portland, Oregon, United States, 97213
Contact: Angi Gill    503-963-2876    NECTARinfo@orclinic.com   
Principal Investigator: Christy Dunst, MD         
United States, Wisconsin
Aurora Medical Center Summit Recruiting
Milwaukee, Wisconsin, United States, 53066
Contact: Kristin Ciezki    414-649-7173    kristin.ciezki@aurora.org   
Principal Investigator: Nimish Vakil, MD         
Sponsors and Collaborators
Impleo Medical Inc.

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Responsible Party: Impleo Medical Inc.
ClinicalTrials.gov Identifier: NCT03090607     History of Changes
Other Study ID Numbers: NECTAR
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No