Gastroesophageal Reflux Disease (GERD)LTFUNCT00587392
Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results
An observational study of Gastroesophageal Reflux Disease (GERD), run by NDO Surgical, Inc. at 7 sites in 2 countries.
Trial summary
The purpose of this study was to gather long-term follow-up data on patients treated with the Plicator in a previous open-label multi-center study. Originally, 64 subjects were treated at seven U.S. sites. 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
- How many people
- 33 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Dec 2004to Sep 2007
- Phase
- Observational
- 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
Study population: Patients previously treated with the NDO Full-thickness Plicator in the original open-label study and who met the long-term Follow-up (LTFU) protocol inclusion and exclusion crieria were eligible for study participation.
Who may be able to join
- History of heartburn or regurgitation for at least 6-months requiring maintenance daily anti-secretory therapy;
- esophageal manometry study demonstrating peristaltic amplitude >35mmHg and LES resting pressure >/=5mmHg;
- Increased esophageal acid exposure demonstrated through a 24-hour pH study.
Who cannot join
- Erosive esophagitis (Savary-Miller grade III or IV);
- Barrett's esophagus;
- Esophageal stricture;
- Hiatal hernia >2cm;
- Persistent dysphagia, weight loss, esophageal bleeding, vomiting or gas-bloat
- Esophageal or gastric varices;
- Use of anticoagulants other than for cardiac prophylaxis
- Pregnancy
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 study was to gather long-term follow-up data on patients treated with the Plicator in a previous open-label multi-center study. Originally, 64 subjects were treated at seven U.S. sites. A subset of those patients were subsequently reassessed via symptom questionnaires in this long-term (60-month) follow-up analysis. The initial open-label study was completed and officially closed at the completion of 1-year follow-up. This current study was designed to collect long-term follow-up data on previously plicated subjects all of whom were recruited de novo from the original study population. Study endpoints were prospectively defined. The primary study objectives were to assess: reduction in GERD symptoms through analysis of the GERD Health Related Quality of Life (HRQL) questionnaire and the Gastrointestinal Symptom Rating Scale (GSRS); reduction in use of GERD medications, and change in overall physical and psychological health as measured by the Short Form Health Survey (SF-36).
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- NDO Full-thickness Plicator
- Keywords
- Gastroesophageal Reflux Disease (GERD), Long-term follow-up (LTFU), 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
The NDO Full-thickness Plicator intervention was performed as part of the original open-label Plicator study as previously reported. This intervention did not take place as part of this long-term follow-up data collection study.
| Study group | Role | What they receive |
|---|---|---|
| A | Active NDO Endoscopic 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.
Reduction of GERD symptoms through analysis of GERD-Health Related Quality of Life (HRQL) questionnaire and Gastrointestinal Symptom Rating Scale (GSRS).
Measured: 3 and 5-years
Secondary outcomes (2)
GERD Medication Use
Measured: 3 and 5-year
Improvement in overall health as measure by the short form Health Survey (SF-36).
Measured: 3 and 5-year
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 startDec 2004
- Primary completionSep 2007
- Study completionSep 2007
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 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 CenterSimon Lo, MD, Principal investigator, Cedars Sinai Medical Center, Lost Angeles, CARichard Rothstein, MD, Principal investigator, Dartmouth Hitchcock Medical Center, Lebanon, NHChristopher Gostout, MD, Principal investigator, Mayo Clinic, Rochester, MNRobert Hawes, MD, Principal investigator, Medical University of South CarolinaNorman Marcon, MD, Principal investigator, St. Michael's Hospital, Toronto, Ontario, CanadaRichard Kozarek, MD, Principal investigator, Virginia Mason Medical Center, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587392
- Sponsor's protocol ID
- 135-01928
- Acronym
- LTFU
- 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, Kozarek R, Haber G, Gostout C, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: long-term multicenter results. Surg Endosc. 2007 Mar;21(3):439-44. doi: 10.1007/s00464-006-9121-8. Epub 2006 Dec 16.
PubMed 17180259Pleskow D, Rothstein R, Kozarek R, Haber G, Gostout C, Lo S, Hawes R, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: Five-year long-term multicenter results. Surg Endosc. 2008 Feb;22(2):326-32. doi: 10.1007/s00464-007-9667-0. Epub 2007 Nov 20.
PubMed 18027032
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
- Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results
- ClinicalTrials.gov ID
- NCT00587392
- Acronym / sponsor ID
- LTFU / 135-01928
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- Gastroesophageal Reflux Disease (GERD), Long-term follow-up (LTFU), Endoscopic Full-thickness Plication, Plicator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- NDO Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (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 study was to gather long-term follow-up data on patients treated with the Plicator in a previous open-label multi-center study. Originally, 64 subjects were treated at seven U.S. sites. A subset of those patients were subsequently reassessed via symptom questionnaires in this long-term (60-month) follow-up analysis. The initial open-label study was completed and officially closed at the completion of 1-year follow-up. This current study was designed to collect long-term follow-up data on previously plicated subjects all of whom were recruited de novo from the original study population. Study endpoints were prospectively defined. The primary study objectives were to assess: reduction in GERD symptoms through analysis of the GERD Health Related Quality of Life (HRQL) questionnaire and the Gastrointestinal Symptom Rating Scale (GSRS); reduction in use of GERD medications, and change in overall physical and psychological health as measured by the Short Form Health Survey (SF-36).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: NDO Full-thickness PlicatorActive NDO Endoscopic Full-thickness Plicator Procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients previously treated with the NDO Full-thickness Plicator in the original open-label study and who met the long-term Follow-up (LTFU) protocol inclusion and exclusion crieria were eligible for study participation.
Key inclusion criteria (3 listed)
- History of heartburn or regurgitation for at least 6-months requiring maintenance daily anti-secretory therapy;
- esophageal manometry study demonstrating peristaltic amplitude >35mmHg and LES resting pressure >/=5mmHg;
- Increased esophageal acid exposure demonstrated through a 24-hour pH study.
Key exclusion criteria (8 listed)
- Erosive esophagitis (Savary-Miller grade III or IV);
- Barrett's esophagus;
- Esophageal stricture;
- Hiatal hernia >2cm;
- Persistent dysphagia, weight loss, esophageal bleeding, vomiting or gas-bloat
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 NDO Full-thickness Plicator intervention was performed as part of the original open-label Plicator study as previously reported. This intervention did not take place as part of this long-term follow-up data collection study. | Device | A |
Primary outcome
Reduction of GERD symptoms through analysis of GERD-Health Related Quality of Life (HRQL) questionnaire and Gastrointestinal Symptom Rating Scale (GSRS).
Time frame: 3 and 5-years
2 secondary outcomes
GERD Medication Use
Time frame: 3 and 5-year
Improvement in overall health as measure by the short form Health Survey (SF-36).
Time frame: 3 and 5-year
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 17180259Pleskow D, Rothstein R, Kozarek R, Haber G, Gostout C, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: long-term multicenter results. Surg Endosc. 2007 Mar;21(3):439-44. doi: 10.1007/s00464-006-9121-8. Epub 2006 Dec 16.
- Results publication: PubMed 18027032Pleskow D, Rothstein R, Kozarek R, Haber G, Gostout C, Lo S, Hawes R, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: Five-year long-term multicenter results. Surg Endosc. 2008 Feb;22(2):326-32. doi: 10.1007/s00464-007-9667-0. Epub 2007 Nov 20.
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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
Simon Lo, MD principal investigator
Cedars Sinai Medical Center, Lost Angeles, CA
Richard Rothstein, MD principal investigator
Dartmouth Hitchcock Medical Center, Lebanon, NH
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease (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 3 inclusion and 8 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?
Reduction of GERD symptoms through analysis of GERD-Health Related Quality of Life (HRQL) questionnaire and Gastrointestinal Symptom Rating Scale (GSRS). (time frame: 3 and 5-years). 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 NCT00587392, 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.