GERDNCT00586859
Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants for the Treatment of GERD
A study testing NDO Full-thickness Plicator in people with GERD, run by NDO Surgical, Inc. at 4 sites in Germany.
Trial summary
The purpose of this study was to evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of GERD. A prospective, multi-center, open-label trial was conducted at four centers in Germany to evaluate a modified Plicator technique for the treatment of patients with symptomatic GERD. 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
- 41 participants
- Where
- 4 sitesGermany
- Study dates
- May 2006to Oct 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 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 an adequate resting pressure of the lower esophageal sphincter (LES) of at least 5 mm Hg.
- 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).
- Symptoms requiring daily PPI therapy.
- GERD-HRQL scores must be > 15 while Off Medication and Off Medication scores must be > 6 points higher than On-Medication scores.
- 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 > 3 cm.
- Presence of persistent dysphagia, weight loss, esophageal bleeding, vomiting (>1 per week) or gas/bloat.
- Esophagitis grades III or IV by Savary criteria.or type C or D by Los Angeles classification .
- Barrett's esophagus with dysplasia.
- Patient has had a previous endoscopic (Endocinch, Stretta, Enteryx, etc.) or surgical repair (Nissen Fundoplication, etc.) performed to treat GERD.
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- 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
4 sites in 1 country.
Germany4 sites
Evangelisches Krankenhaus
Düsseldorf, 40217
Markus-Krankenhaus
Frankfurt, 60431
Medizinische Klinik und Poliklinik Universitatsklinikum Leipzig
Leipzig, D-04103
Klinikum Ludwigsburg
Ludwigsburg, 71640
About this study
Official title: Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants
The purpose of this study was to evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of GERD.
A prospective, multi-center, open-label trial was conducted at four centers in Germany to evaluate a modified Plicator technique for the treatment of patients with symptomatic GERD. Primary efficacy was based on analysis of the GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment. Additional efficacy outcomes assessed were heartburn and regurgitation symptoms scores, visual analog scale (VAS) score, GERD medication use, esophageal pH/manometry, and esophagitis. Trial sample size was chosen to provide 87% power in detecting a 50% median reduction in GERD-HRQL score at an alpha level of 0.05.
- 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. Additional sutures were placed in the same manner described above, with each additional implant placed incrementally closer to the GE junction in a linear configuration along the anterior gastric cardia. All plications were placed de novo, and re-treatment was not permitted.
| 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.
GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment
Measured: 1, 6, 12, 24, 36, 48 and 60-month post-treatment
Secondary outcomes (7)
Heartburn Score
Measured: 1, 6, 12, 24, 36, 48 and 60-months post-treatment
Regurgitation score
Measured: 1, 6, 12, 24, 36, 48 and 60-months post-treatment
GERD symptom improvement as measured by a visual analog scale
Measured: 1, 6, 12. 24, 36, 48 and 60-months post-treatment
GERD medication use
Measured: 1, 6, 12, 24, 36, 48 and 60-months post-treatment
Esophageal acid exposure
Measured: 6-months post-treatment
Esophageal sphincter (LES) resting pressure as measure by manometry
Measured: 6-months post-treatment
Esophagitis score
Measured: 6-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 posted7 Jan 2008 (estimated)
- Study startMay 2006
- Primary completionOct 2007
- Study completionOct 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- NDO Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586859
- Sponsor's protocol ID
- 135-02420
- Status last verified
- May 2008
- First submitted
- 21 Dec 2007
- 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
- Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants
- ClinicalTrials.gov ID
- NCT00586859
- Acronym / sponsor ID
- 135-02420
- Conditions
- GERD
- Keywords
- Gastroesophageal Reflux Disease (GERD), NDO Full-thickness Plicator, Plicator, Endoluminal GERD Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsoring company ceased business operations.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- NDO Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 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 evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of GERD.
A prospective, multi-center, open-label trial was conducted at four centers in Germany to evaluate a modified Plicator technique for the treatment of patients with symptomatic GERD. Primary efficacy was based on analysis of the GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment. Additional efficacy outcomes assessed were heartburn and regurgitation symptoms scores, visual analog scale (VAS) score, GERD medication use, esophageal pH/manometry, and esophagitis. Trial sample size was chosen to provide 87% power in detecting a 50% median reduction in GERD-HRQL score at an alpha level of 0.05.
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 (8 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 an adequate resting pressure of the lower esophageal sphincter (LES) of at least 5 mm Hg.
- 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).
- Symptoms requiring daily PPI therapy.
Key exclusion criteria (12 listed)
- Patient is pregnant.
- Patient has hiatal hernia > 3 cm.
- Presence of persistent dysphagia, weight loss, esophageal bleeding, vomiting (>1 per week) or gas/bloat.
- Esophagitis grades III or IV by Savary criteria.or type C or D by Los Angeles classification .
- Barrett's esophagus with dysplasia.
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. Additional sutures were placed in the same manner described above, with each additional implant placed incrementally closer to the GE junction in a linear configuration along the anterior gastric cardia. All plications were placed de novo, and re-treatment was not permitted. | Device | A |
Primary outcome
GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment
Time frame: 1, 6, 12, 24, 36, 48 and 60-month post-treatment
7 secondary outcomes
Heartburn Score
Time frame: 1, 6, 12, 24, 36, 48 and 60-months post-treatment
Regurgitation score
Time frame: 1, 6, 12, 24, 36, 48 and 60-months post-treatment
GERD symptom improvement as measured by a visual analog scale
Time frame: 1, 6, 12. 24, 36, 48 and 60-months post-treatment
GERD medication use
Time frame: 1, 6, 12, 24, 36, 48 and 60-months post-treatment
Esophageal acid exposure
Time frame: 6-months post-treatment
Esophageal sphincter (LES) resting pressure as measure by manometry
Time frame: 6-months post-treatment
Esophagitis score
Time frame: 6-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.
4 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 4 sites in Germany.
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 8 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: 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 4 sites in 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. 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?
GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment (time frame: 1, 6, 12, 24, 36, 48 and 60-month 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.