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Trial record 51 of 189 for:    gastroenterology | Recruiting Studies | United States

Novel Endoluminal Clinical TreAtment of Reflux (NECTAR)

This study is currently recruiting participants.
Verified December 2017 by Impleo Medical Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03090607
First Posted: March 27, 2017
Last Update Posted: December 5, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Impleo Medical Inc.
  Purpose
This is a prospective, multi-center, double-blind randomized controlled trial designed to demonstrate the safety and efficacy of Aluvra for the treatment of GERD.

Condition Intervention
GERD Device: Aluvra™ Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel 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

Resource links provided by NLM:


Further study details as provided by Impleo Medical Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Actual Study Start Date: November 1, 2017
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   22 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
Contact: sharona segal-leibovich 6128453667 ssegal@impleomedical.com
Contact: Juliana Elstad jelstad@impleomedical.com

Locations
United States, California
Digestive Health Center Recruiting
Palo Alto, California, United States, 94304
Contact: Divya Pathak    650-721-9436    Divya22@stanford.edu   
Principal Investigator: John Clarke, MD         
United States, Minnesota
Minnesota Gastroenterology, P.A Recruiting
Plymouth, Minnesota, United States, 55446
Contact: Andrea Gruber    612-870-5599    andrea.gruber@mngastro.com   
Principal Investigator: Robert Ganz, 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, Wisconsin
Aurora Medical Center Summit Recruiting
Milwaukee, Wisconsin, United States, 53066
Contact: Kristin Ciezki    262-434-3112    kristin.ciezki@aurora.org   
Principal Investigator: Nimish Vakil, MD         
Sponsors and Collaborators
Impleo Medical Inc.
  More Information

Responsible Party: Impleo Medical Inc.
ClinicalTrials.gov Identifier: NCT03090607     History of Changes
Other Study ID Numbers: NECTAR
First Submitted: March 15, 2017
First Posted: March 27, 2017
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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