GERDNCT00597792
Registry Study of the NDO Surgical Plicator for the Treatment of GERD
A study testing NDO Full-thickness Plicator in people with GERD, run by NDO Surgical, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to collect post-marketing data on patient outcomes and satisfaction following treatment with the Plicator™. The outcomes will be tracked through analysis of patient Quality of Life (QoL) questionnaires and medication use. 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
- 131 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2004to Nov 2007
- 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 suitable for surgery (American Society of Anesthesiologists Physical Status Classification I or II).
- Subject agrees to study participation and signs/dates an informed consent form.
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
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Evanston Northwestern Healthcare
Evanston, Illinois, 60201
Digestive Associates of Houston
Houston, Texas, 77030
Northside Gastroenterology, Inc.
Indianapolis, Indiana, 46260
Medical Center of Central Georgia
Macon, Georgia, 31201
Nashville Medical Research and the Maria Nathanson Center of Excellence
Nashville, Tennessee, 37205
Lenox Hill Hospital
New York, New York, 10021
Stony brook University Medical Center
Stony Brook, New York, 11794
About this study
The purpose of this study is to collect post-marketing data on patient outcomes and satisfaction following treatment with the Plicator™. The outcomes will be tracked through analysis of patient Quality of Life (QoL) questionnaires and medication use. The QoL and medication use questionaires will be administered and documented twice before the procedure and then again at outlined intervals following the procedure. Additionally, financial measures will be evaluated (i.e. pre-procedural and procedural time and costs, staffing/personnel needs during procedure, anesthesia and related costs, recovery time and associated cost, etc.) and post-procedure GERD-related medical history questionnaires will be completed.
This post-market evaluation is a multi-center study design using the NDO Surgical, Inc. Plicator as the treatment device. Treatment efficacy will be evaluated by comparing QoL and medication use before and after treatment with the device. Patient follow-ups will be completed at 1 week and at 6, 12, 24, 36, 48 and 60 months post treatment.
- Conditions
- GERD
- Being tested
- NDO Full-thickness Plicator
- Keywords
- Gastroesophageal Reflux Disease (GERD), Plicator, Full-thickness Plication
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Active Plicator Treatment Receives: Device: NDO Full-thickness Plicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Measured: 6, 12, 24, 36, 48, 60 months post-treatment
Secondary outcomes (3)
GERD Medication Use
Measured: 6, 12, 24, 36, 48, 60 months post-treatment
Economic outcomes (e.g. procedure time/costs, staffing needs, anesthesia costs, recovery time/costs)
Measured: 6, 12, 24, 36, 48, 60 months post-procedure
Subject satisfaction
Measured: 6, 12, 24, 36, 48, 60 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startAug 2004
- Primary completionNov 2007
- Study completionNov 2007
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- NDO Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597792
- Sponsor's protocol ID
- 135-01762
- Status last verified
- May 2008
- First submitted
- 9 Jan 2008
- Last updated
- 30 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study of the NDO Surgical Plicator for the Treatment of GERD
- ClinicalTrials.gov ID
- NCT00597792
- Acronym / sponsor ID
- 135-01762
- Conditions
- GERD
- Keywords
- Gastroesophageal Reflux Disease (GERD), Plicator, Full-thickness Plication
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsoring company ceased business operations
- Enrolment
- 131 participants (actual)
- Lead sponsor
- NDO Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 18 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 is to collect post-marketing data on patient outcomes and satisfaction following treatment with the Plicator™. The outcomes will be tracked through analysis of patient Quality of Life (QoL) questionnaires and medication use. The QoL and medication use questionaires will be administered and documented twice before the procedure and then again at outlined intervals following the procedure. Additionally, financial measures will be evaluated (i.e. pre-procedural and procedural time and costs, staffing/personnel needs during procedure, anesthesia and related costs, recovery time and associated cost, etc.) and post-procedure GERD-related medical history questionnaires will be completed.
This post-market evaluation is a multi-center study design using the NDO Surgical, Inc. Plicator as the treatment device. Treatment efficacy will be evaluated by comparing QoL and medication use before and after treatment with the device. Patient follow-ups will be completed at 1 week and at 6, 12, 24, 36, 48 and 60 months post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: NDO Full-thickness PlicatorActive Plicator Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is suitable for surgery (American Society of Anesthesiologists Physical Status Classification I or II).
- Subject agrees to study participation and signs/dates an informed consent form.
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 PlicatorA 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 | A |
Primary outcome
Quality of Life
Time frame: 6, 12, 24, 36, 48, 60 months post-treatment
3 secondary outcomes
GERD Medication Use
Time frame: 6, 12, 24, 36, 48, 60 months post-treatment
Economic outcomes (e.g. procedure time/costs, staffing needs, anesthesia costs, recovery time/costs)
Time frame: 6, 12, 24, 36, 48, 60 months post-procedure
Subject satisfaction
Time frame: 6, 12, 24, 36, 48, 60 months post-treatment
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 30 May 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: 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 United States.
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 2 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 30 May 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. 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 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?
Quality of Life (time frame: 6, 12, 24, 36, 48, 60 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2008; AzTrials last refreshed its copy on 7 Nov 2026.