Gastroesophageal Reflux Disease (GERD)NCT00575822
A Study to Determine the Effectiveness of Endoscopic Full-Thickness Plication for the Treatment of GERD
A study testing NDO Full-thickness Plicator in people with Gastroesophageal Reflux Disease (GERD), run by NDO Surgical, Inc. at 15 sites in 3 countries.
Trial summary
The aim of this study was to determine the effectiveness of endoscopic full-thickness plication (Plicator; NDO Surgical, Inc., Mansfield, MA) for the treatment of GERD in comparison to a sham procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- NDO Full-thickness Plicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Jan 2005to Mar 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GERD-HRQL score ≥ 15 while off PPI therapy, and at least 6 points higher than on-PPI score
- Pathologic esophageal acid exposure, defined as pH<4.0 ≥ 4.5% of a 24- or 48-hour monitoring period or a DeMeester score > 14.7
- Lower esophageal resting pressure of at least 5mmHg; and
- Suitability for surgery (American Society of Anesthesiologists Physical Status Classification I or II).
Who cannot join
- Significant esophageal dysmotility as determined by manometry
- Esophagitis grade III or IV (Savary-Miller)
- Barrett's epithelium
- Hiatus hernia > 2cm
- Persistent dysphagia, weight loss, esophageal bleeding, vomiting, gas or bloating
- Esophageal or gastric varices
Show all 10Show fewer
- Previous endoscopic or surgical anti-reflux procedure
- Other esophageal or gastric surgery
- Chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis); and
- Pregnancy.
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States13 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Colorado Health Science Center
Denver, Colorado, 80010
Seacoast Gastroenterology
Exeter, New Hampshire, 03833
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Nashville Medical Research and the Maria Nathanson Center of Excellence
Nashville, Tennessee, 37205
Vanderbilt University Medical Center
Nashville, Tennessee, 37240
Lenox Hill Hospital
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
Creighton University Medical Center
Omaha, Nebraska, 68131
University of California at Irvine Medical Center
Orange, California, 92868
Tri Valley Gastroenterology
San Ramon, California, 94583
Virginia Mason Medical Center
Seattle, Washington, 98101
Digestive Health Specialists
Tacoma, Washington, 98405
Germany1 site
Klinikum Ludwigsburg, University of Heidelburg
Heidelberg, 71640
About this study
Official title: Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial
The aim of this study was to determine the effectiveness of endoscopic full-thickness plication (Plicator; NDO Surgical, Inc., Mansfield, MA) for the treatment of GERD in comparison to a sham procedure.
Patients with symptomatic GERD requiring maintenance proton pump inhibitor therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary endpoint was ≥ 50% improvement in GERD-HRQL score. Secondary endpoints included medication use and esophageal acid exposure.
Patients achieving ≥ 50% improvement in GERD-HRQL score at 3-months versus baseline off-meds were considered responsive to their assigned procedure. Patients who failed to reach this level of improvement at 3-months were considered non-responders. Analysis of these dichotomized variables (responder/non-responder) was done using Fisher's exact test comparing the proportion of responders between the active and sham groups. Intent-to-treat analysis was also performed. The null hypothesis was that the proportion of responders was the same in both the active and sham groups. Testing was done at the 5% level of significance (alpha=0.05).
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- NDO Full-thickness Plicator, Sham Control
- Keywords
- GERD, Sham, Randomized Controlled Study, Endoscopic Full-thickness Plication, Plicator
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDO Full-thickness PlicatorDevice
Also called Active Plicator procedure
A low-profile (≤6mm) gastroscope was advanced and an EGD followed by Savary wire placement was performed. The gastroscope was then removed and the Plicator was advanced directly over the wire and into the stomach. The gastroscope was re-introduced through the Plicator, and the Plicator was retroflexed under direct endoscopic visualization to the anterior gastric cardia, approximately 1cm below the gastroesophageal (GE) junction. The Plicator arms were opened and the endoscopic tissue retractor was advanced deeply into the gastric cardia. The gastric wall was then retracted into the open arms of the Plicator. The arms were closed and a single, transmural pledgeted suture was deployed. The Plicator and gastroscope were then removed and the gastroscope re-inserted to evaluate the post-plication GE junction.
Sham ControlDevice
Also called Sham control procedure
The sham procedure was identical to the treatment procedure through the positioning of the retroflexed Plicator 1cm below the GE junction. The Plicator instrument remained in this position for 15 minutes, based on average procedure times established in previous studies. During the sham procedure, physician investigators were required to talk through the procedure steps to maintain the patient blind.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | NDO Endoscopic Full-thickness Plicator procedure Receives: Device: NDO Full-thickness Plicator |
| 2 | Sham comparator | Sham control procedure Receives: Device: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
>/=50% improvement in GERD-Health Related Quality of Life Score
Measured: 3-months post-procedure
Secondary outcomes (4)
GERD medication use
Measured: 3-months post-procedure
Esophageal acid exposure
Measured: 3-months post-procedure
Heartburn score as measure by visual analog scale
Measured: 3-months post-procedure
Quality of Life as measure by SF-36
Measured: 3-months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startJan 2005
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: Sponsoring company ceased business operations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- NDO Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Rothstein, MD, Principal investigator, Dartmouth-Hitchcock Medical Center, Lebanon, NHCharles Filipi, MD, Principal investigator, Creighton University Medical Center, Omaha, NEKarel Caca, MD, Principal investigator, Klinikum Ludwigsburg, University of Heidelburg, Heidelburg, GermanyRonald Pruitt, MD, Principal investigator, Nashville Medical Research and the Maria Nathanson Center of Excellence, Nashville, TNKlaus Mergener, MD, Principal investigator, Digestive Health Specialists, Tacoma, WAAlfonso Torquati, MD, Principal investigator, Vanderbilt University Medical Center, Nashville, TNGregory Haber, MD, Principal investigator, Lenox Hill Hospital, New York, NYYang Chen, MD, Principal investigator, University of Colorado Health Science Center, Denver, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575822
- Sponsor's protocol ID
- 135-01885
- Status last verified
- May 2008
- First submitted
- 14 Dec 2007
- Last updated
- 16 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Rothstein R, Filipi C, Caca K, Pruitt R, Mergener K, Torquati A, Haber G, Chen Y, Chang K, Wong D, Deviere J, Pleskow D, Lightdale C, Ades A, Kozarek R, Richards W, Lembo A. Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A randomized, sham-controlled trial. Gastroenterology. 2006 Sep;131(3):704-12. doi: 10.1053/j.gastro.2006.07.004.
PubMed 16952539
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT00575822
- Acronym / sponsor ID
- 135-01885
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- GERD, Sham, Randomized Controlled Study, Endoscopic Full-thickness Plication, Plicator
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsoring company ceased business operations.
- Enrolment
- 159 participants (actual)
- Lead sponsor
- NDO Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 18 Dec 2007 (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 aim of this study was to determine the effectiveness of endoscopic full-thickness plication (Plicator; NDO Surgical, Inc., Mansfield, MA) for the treatment of GERD in comparison to a sham procedure.
Patients with symptomatic GERD requiring maintenance proton pump inhibitor therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary endpoint was ≥ 50% improvement in GERD-HRQL score. Secondary endpoints included medication use and esophageal acid exposure.
Patients achieving ≥ 50% improvement in GERD-HRQL score at 3-months versus baseline off-meds were considered responsive to their assigned procedure. Patients who failed to reach this level of improvement at 3-months were considered non-responders. Analysis of these dichotomized variables (responder/non-responder) was done using Fisher's exact test comparing the proportion of responders between the active and sham groups. Intent-to-treat analysis was also performed. The null hypothesis was that the proportion of responders was the same in both the active and sham groups. Testing was done at the 5% level of significance (alpha=0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: NDO Full-thickness PlicatorNDO Endoscopic Full-thickness Plicator procedure |
| 2 | Sham comparator | Device: Sham ControlSham control procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- GERD-HRQL score ≥ 15 while off PPI therapy, and at least 6 points higher than on-PPI score
- Pathologic esophageal acid exposure, defined as pH<4.0 ≥ 4.5% of a 24- or 48-hour monitoring period or a DeMeester score > 14.7
- Lower esophageal resting pressure of at least 5mmHg; and
- Suitability for surgery (American Society of Anesthesiologists Physical Status Classification I or II).
Key exclusion criteria (10 listed)
- Significant esophageal dysmotility as determined by manometry
- Esophagitis grade III or IV (Savary-Miller)
- Barrett's epithelium
- Hiatus hernia > 2cm
- Persistent dysphagia, weight loss, esophageal bleeding, vomiting, gas or bloating
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 |
|---|---|---|
| NDO Full-thickness PlicatorAlso: Active Plicator procedureA low-profile (≤6mm) gastroscope was advanced and an EGD followed by Savary wire placement was performed. The gastroscope was then removed and the Plicator was advanced directly over the wire and into the stomach. The gastroscope was re-introduced through the Plicator, and the Plicator was retroflexed under direct endoscopic visualization to the anterior gastric cardia, approximately 1cm below the gastroesophageal (GE) junction. The Plicator arms were opened and the endoscopic tissue retractor was advanced deeply into the gastric cardia. The gastric wall was then retracted into the open arms of the Plicator. The arms were closed and a single, transmural pledgeted suture was deployed. The Plicator and gastroscope were then removed and the gastroscope re-inserted to evaluate the post-plication GE junction. | Device | 1 |
| Sham ControlAlso: Sham control procedureThe sham procedure was identical to the treatment procedure through the positioning of the retroflexed Plicator 1cm below the GE junction. The Plicator instrument remained in this position for 15 minutes, based on average procedure times established in previous studies. During the sham procedure, physician investigators were required to talk through the procedure steps to maintain the patient blind. | Device | 2 |
Primary outcome
>/=50% improvement in GERD-Health Related Quality of Life Score
Time frame: 3-months post-procedure
4 secondary outcomes
GERD medication use
Time frame: 3-months post-procedure
Esophageal acid exposure
Time frame: 3-months post-procedure
Heartburn score as measure by visual analog scale
Time frame: 3-months post-procedure
Quality of Life as measure by SF-36
Time frame: 3-months post-procedure
Results and safety
The study was stopped early (reason given: Sponsoring company ceased business operations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2008.
- Results publication: PubMed 16952539Rothstein R, Filipi C, Caca K, Pruitt R, Mergener K, Torquati A, Haber G, Chen Y, Chang K, Wong D, Deviere J, Pleskow D, Lightdale C, Ades A, Kozarek R, Richards W, Lembo A. Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A randomized, sham-controlled trial. Gastroenterology. 2006 Sep;131(3):704-12. doi: 10.1053/j.gastro.2006.07.004.
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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.
Richard Rothstein, MD principal investigator
Dartmouth-Hitchcock Medical Center, Lebanon, NH
Charles Filipi, MD principal investigator
Creighton University Medical Center, Omaha, NE
Karel Caca, MD principal investigator
Klinikum Ludwigsburg, University of Heidelburg, Heidelburg, Germany
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NDO Full-thickness Plicator in people with Gastroesophageal Reflux Disease (GERD), run by NDO Surgical, Inc. at 15 sites in 3 countries.
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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 16 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Belgium, Germany. 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?
The study was stopped early (reason given: Sponsoring company ceased business operations.). 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?
>/=50% improvement in GERD-Health Related Quality of Life Score (time frame: 3-months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00575822, which also lists 1 linked publication.
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 16 Jul 2008.