GERDNCT00587522
Study of the NDO Endoscopic Plication System For the Treatment of Symptomatic Gastroesophageal Reflux Disease
A study testing NDO Full-thickness Plicator in people with GERD, run by NDO Surgical, Inc. at 7 sites in 2 countries.
Trial summary
The purpose of this prospective, multicenter study was to evaluate the safety and efficacy of endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux. Sixty-four patients were enrolled and underwent endoscopic full-thickness plication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD
- What is being tested?
- NDO Full-thickness Plicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Aug 2001to May 2003
- 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
- Subject is 18 years of age or older.
- History of heartburn or regurgitation for at least ¬6 months.
- Esophageal manometry study (conducted within the previous 6 months) demonstrating adequate esophageal peristalsis (defined as a mean amplitude of contraction in the esophageal body of > 35 mm Hg) and a resting pressure of the lower esophageal sphincter (LES) of at least 5 mm Hg.
- 24 hour pH study (conducted within the previous 6 months) demonstrating pathological reflux (defined as the total % time of pH<4.0 > 4.5% or a DeMeester composite score > 14.7).
- Significant relief of symptoms with PPI therapy.
- Subject is a surgical candidate in the event of a complication related to this procedure, Class ASA I or II.
- Subject agrees to participate and signs consent form.
Who cannot join
- Patient is pregnant.
- Patient has hiatal hernia > 2 cm.
- Presence of persistent dysphagia, weight loss, esophageal bleeding, vomiting (>1 per week) or gas/bloat.
- Esophagitis grades III or IV by Savary criteria.
- Barrett's esophagus.
- Patients Baseline Off-Meds GERD-HRQL score <12.
Show all 12Show fewer
- Active medical condition that would preclude the subject from finishing this study.
- Abnormal blood coagulation or the chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis).
- Pathological changes in soft tissue that would prevent secure fixation of the EPS Implant.
- Presence of esophageal or gastric varices.
- Esophageal dysmotility as determined by manometry studies.
- Esophageal stricture.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Cedars Sinai Medical Center
Los Angeles, California, 90048
Mayo Clinic
Rochester, Minnesota, 55905
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
The purpose of this prospective, multicenter study was to evaluate the safety and efficacy of endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux.
Sixty-four patients were enrolled and underwent endoscopic full-thickness plication. All patients received a single implant/plication. No repeat plication procedures were performed.
Primary efficacy in this study was measured by the percent reduction in post-procedure GERD symptoms as evidenced by analysis of the GERD-HRQL (Health Related Quality of Life) questionnaire. Secondary efficacy outcomes included post-procedure reduction in anti-secretory therapy, improvement in quality of life questionnaires, reduction in distal esophageal acid exposure, and improvement in esophageal manometry. Patient follow-up assessments were completed at 1, 3, 6 and 12 months post treatment.
Read the detailed description
The primary objective for this study was to measure the reduction in GERD symptoms as evidenced by analysis of the GERD-HRQL questionnaire at 3-months post-procedure with an objective of achieving a 50% or greater improvement. The trial was powered to detect a 50% reduction in mean GERD-HRQL at 3-months using a one-sided t-test with an α of .05 and a β level of .10, testing versus the equality of means. The calculation referenced above includes the added assumption that the standard deviation will be no more than 20 percent. The null hypothesis stated that the mean percent reduction in GERD symptoms was less than or equal to 50 percent at 3-months versus the alternate hypothesis that it was greater. The device treatment was considered a success if the statistical test rejected the null hypothesis at a one-sided p-value of 0.05 or less. Primary endpoint success was thus related to the statistical conclusion that the mean percent reduction was greater than 50%. A one-sided 95 percent confidence interval was constructed for the percent reduction in GERD symptoms. In order to assess the data with an "Intent to Treat" spirit, the number of patients who achieved a 50% reduction was analyzed as a fraction of the total number of patients who received the treatment.
For secondary endpoint measures, statistical tests for medians were based on a Wilcoxon sign rank test of the percent improvement in a given study measure. This was based on the paired patient data of the pre-treatment scores versus the 6-month scores. The issue of multiple statistical tests of hypothesis being performed on data arising from individual patients was addressed in the following way. The comparison of GERD-HRQL scores was taken as the main results for which no correction of significance level was necessary. To recognize multiple testing using the method of Bonferroni, statistical significance was claimed for the secondary results only if, for a single test, the nominal p-value was <.01. Given that some patients, during the course of the clinical study, were lost to follow-up, all outcomes were examined using the method of last visit carried forward, provided that at least one follow-up visit had been completed. It should be noted that using this method had little impact on the results; as compared to an analysis of the data of just those patients who completed follow-up, excluding those who missed the visit or were lost to follow up. However, this method was employed to account for those patients who were lost to follow-up, with specific consideration to those who had been lost to follow-up due to unsatisfactory treatment effect. Means and standard deviations are reported using the mean (SD) format, medians and interquartile ranges are reported using the median (IQR) format.
- Conditions
- GERD
- Being tested
- NDO Full-thickness Plicator
- Keywords
- Gastroesophageal Reflux Disease (GERD), NDO Full-thickness Plicator, Plicator, Endoluminal GERD Therapy
- 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
The Plicator and gastroscope assembly were passed into the stomach. The stomach was distended with air. The gastroscope was advanced and retroflexed so that the instrument could be visualized and accurately positioned. The Plicator was retroflexed to within 1cm below the GE junction, and the helical tissue retractor was advanced deeply into the gastric wall. The gastric wall was retracted into the Plicator instrument arms. The arms were then closed, and the suture-implant was deployed to secure the full-thickness plication. The tissue retractor is then disengaged and the suture-implant released from the instrument.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | NDO Full-thickness Plicator Procedure Receives: Device: NDO Full-thickness Plicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in GERD symptoms as evidenced by analysis of the GERD-Health Related Quality of Life (HRQL)questionnaire.
Measured: 3, 6 and 12 months
Secondary outcomes (4)
GERD Medication Use
Measured: 3, 6 and 12 months
Improvement in Quality of Life Questionnaires (GERD-HRQL, Gastrointestinal Symptom Rating Scale-GSRS and SF-36)
Measured: 3, 6 and 12 months
Esophageal acid exposure
Measured: 3 and 6 months
Esophageal manometry
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startAug 2001
- Primary completionMay 2003
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- NDO Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Douglas Pleskow, MD, Principal investigator, Beth Israel Deaconess Medical CenterRichard Rothstein, MD, Principal investigator, Dartmouth Hitchcock Medical Center, Lebanon, NHSimon Lo, MD, Principal investigator, Cedars Sinai Medical Center, Los Angeles, CARobert Hawes, MD, Principal investigator, Medical University of South CarolinaRichard Kozarek, MD, Principal investigator, Virginia Mason Medical Center, Seattle, WAGregory Haber, MD, Principal investigator, St. Michael's Hospital, Toronto, Ontario, CanadaChristopher Gostout, MD, Principal investigator, Mayo Clinic, Rochester, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587522
- Sponsor's protocol ID
- 135-00274
- Status last verified
- Dec 2007
- First submitted
- 21 Dec 2007
- Last updated
- 7 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Pleskow D, Rothstein R, Lo S, Hawes R, Kozarek R, Haber G, Gostout C, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: a multicenter trial. Gastrointest Endosc. 2004 Feb;59(2):163-71. doi: 10.1016/s0016-5107(03)02542-2.
PubMed 14745387Pleskow D, Rothstein R, Lo S, Hawes R, Kozarek R, Haber G, Gostout C, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: 12-month follow-up for the North American open-label trial. Gastrointest Endosc. 2005 May;61(6):643-9. doi: 10.1016/s0016-5107(04)02648-3.
PubMed 15855966
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the NDO Endoscopic Plication System For the Treatment of Symptomatic Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT00587522
- Acronym / sponsor ID
- 135-00274
- Conditions
- GERD
- Keywords
- Gastroesophageal Reflux Disease (GERD), NDO Full-thickness Plicator, Plicator, Endoluminal GERD Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- NDO Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 7 Jan 2008 (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 purpose of this prospective, multicenter study was to evaluate the safety and efficacy of endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux.
Sixty-four patients were enrolled and underwent endoscopic full-thickness plication. All patients received a single implant/plication. No repeat plication procedures were performed.
Primary efficacy in this study was measured by the percent reduction in post-procedure GERD symptoms as evidenced by analysis of the GERD-HRQL (Health Related Quality of Life) questionnaire. Secondary efficacy outcomes included post-procedure reduction in anti-secretory therapy, improvement in quality of life questionnaires, reduction in distal esophageal acid exposure, and improvement in esophageal manometry. Patient follow-up assessments were completed at 1, 3, 6 and 12 months post treatment.
Detailed description
The primary objective for this study was to measure the reduction in GERD symptoms as evidenced by analysis of the GERD-HRQL questionnaire at 3-months post-procedure with an objective of achieving a 50% or greater improvement. The trial was powered to detect a 50% reduction in mean GERD-HRQL at 3-months using a one-sided t-test with an α of .05 and a β level of .10, testing versus the equality of means. The calculation referenced above includes the added assumption that the standard deviation will be no more than 20 percent. The null hypothesis stated that the mean percent reduction in GERD symptoms was less than or equal to 50 percent at 3-months versus the alternate hypothesis that it was greater. The device treatment was considered a success if the statistical test rejected the null hypothesis at a one-sided p-value of 0.05 or less. Primary endpoint success was thus related to the statistical conclusion that the mean percent reduction was greater than 50%. A one-sided 95 percent confidence interval was constructed for the percent reduction in GERD symptoms. In order to assess the data with an "Intent to Treat" spirit, the number of patients who achieved a 50% reduction was analyzed as a fraction of the total number of patients who received the treatment.
For secondary endpoint measures, statistical tests for medians were based on a Wilcoxon sign rank test of the percent improvement in a given study measure. This was based on the paired patient data of the pre-treatment scores versus the 6-month scores. The issue of multiple statistical tests of hypothesis being performed on data arising from individual patients was addressed in the following way. The comparison of GERD-HRQL scores was taken as the main results for which no correction of significance level was necessary. To recognize multiple testing using the method of Bonferroni, statistical significance was claimed for the secondary results only if, for a single test, the nominal p-value was <.01. Given that some patients, during the course of the clinical study, were lost to follow-up, all outcomes were examined using the method of last visit carried forward, provided that at least one follow-up visit had been completed. It should be noted that using this method had little impact on the results; as compared to an analysis of the data of just those patients who completed follow-up, excluding those who missed the visit or were lost to follow up. However, this method was employed to account for those patients who were lost to follow-up, with specific consideration to those who had been lost to follow-up due to unsatisfactory treatment effect. Means and standard deviations are reported using the mean (SD) format, medians and interquartile ranges are reported using the median (IQR) format.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: NDO Full-thickness PlicatorNDO Full-thickness Plicator Procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is 18 years of age or older.
- History of heartburn or regurgitation for at least ¬6 months.
- Esophageal manometry study (conducted within the previous 6 months) demonstrating adequate esophageal peristalsis (defined as a mean amplitude of contraction in the esophageal body of > 35 mm Hg) and a resting pressure of the lower esophageal sphincter (LES) of at least 5 mm Hg.
- 24 hour pH study (conducted within the previous 6 months) demonstrating pathological reflux (defined as the total % time of pH<4.0 > 4.5% or a DeMeester composite score > 14.7).
- Significant relief of symptoms with PPI therapy.
Key exclusion criteria (12 listed)
- Patient is pregnant.
- Patient has hiatal hernia > 2 cm.
- Presence of persistent dysphagia, weight loss, esophageal bleeding, vomiting (>1 per week) or gas/bloat.
- Esophagitis grades III or IV by Savary criteria.
- 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 |
|---|---|---|
| NDO Full-thickness PlicatorThe Plicator and gastroscope assembly were passed into the stomach. The stomach was distended with air. The gastroscope was advanced and retroflexed so that the instrument could be visualized and accurately positioned. The Plicator was retroflexed to within 1cm below the GE junction, and the helical tissue retractor was advanced deeply into the gastric wall. The gastric wall was retracted into the Plicator instrument arms. The arms were then closed, and the suture-implant was deployed to secure the full-thickness plication. The tissue retractor is then disengaged and the suture-implant released from the instrument. | Device | A |
Primary outcome
Percent reduction in GERD symptoms as evidenced by analysis of the GERD-Health Related Quality of Life (HRQL)questionnaire.
Time frame: 3, 6 and 12 months
4 secondary outcomes
GERD Medication Use
Time frame: 3, 6 and 12 months
Improvement in Quality of Life Questionnaires (GERD-HRQL, Gastrointestinal Symptom Rating Scale-GSRS and SF-36)
Time frame: 3, 6 and 12 months
Esophageal acid exposure
Time frame: 3 and 6 months
Esophageal manometry
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2008.
- Results publication: PubMed 14745387Pleskow D, Rothstein R, Lo S, Hawes R, Kozarek R, Haber G, Gostout C, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: a multicenter trial. Gastrointest Endosc. 2004 Feb;59(2):163-71. doi: 10.1016/s0016-5107(03)02542-2.
- Results publication: PubMed 15855966Pleskow D, Rothstein R, Lo S, Hawes R, Kozarek R, Haber G, Gostout C, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: 12-month follow-up for the North American open-label trial. Gastrointest Endosc. 2005 May;61(6):643-9. doi: 10.1016/s0016-5107(04)02648-3.
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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.
Douglas Pleskow, MD principal investigator
Beth Israel Deaconess Medical Center
Richard Rothstein, MD principal investigator
Dartmouth Hitchcock Medical Center, Lebanon, NH
Simon Lo, MD principal investigator
Cedars Sinai Medical Center, Los Angeles, CA
7 sites in 2 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 GERD, run by NDO Surgical, Inc. at 7 sites in 2 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 7 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent reduction in GERD symptoms as evidenced by analysis of the GERD-Health Related Quality of Life (HRQL)questionnaire. (time frame: 3, 6 and 12 months). 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 NCT00587522, which also lists 2 linked publications.
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 7 Jan 2008.