Non-acid Reflux DiseaseNCT01241149
Prospective Evaluation of Symptom Resolution in Acid Versus Non-acid Reflux Disease Following Anti-reflux Surgery
A study testing anti-reflux surgery in people with Non-acid Reflux Disease, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
Trial summary
Gastroesophageal reflux disease (GERD) is a common ailment affecting a significant portion of the US population. With the advent and increased use of esophageal impedance monitoring, both acid and nonacid reflux disease can be better diagnosed and treated. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Non-acid Reflux Disease
- What is being tested?
- anti-reflux surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to 26 Mar 2014
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are offered anti-reflux surgical treatment with elevated DeMeester scores or with low (less than 14.7) DeMeester scores, but with positive impedance scores (positive symptom index associated with reflux episodes).
Who cannot join
- • Previous major upper gastrointestinal surgery (includes esophagus, stomach, and duodenum) - previous cholecystectomy (gallbladder removal) is not considered a major upper GI surgery
- Presence of paraesophageal hernia (type II - type IV)
- Presence of large hiatal hernia >5cm
- Presence of peptic strictures
- History of severe esophageal motility disorders such as:
- achalasia
Show all 16Show fewer
- diffuse esophageal spasms
- scleroderma
- poorly-controlled diabetes mellitus
- autonomic or peripheral neuropathy
- myopathy
- Pregnancy (As a standard operating procedure, women of child-bearing age will undergo a urine pregnancy test the morning of surgery because anti-reflux surgery is considered an elective case, where pregnancy is a relative contraindication.)
- BMI greater than 40
- Undergoes Collis gastroplasty during surgery
- Conversion to an open procedure
- Age less than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
About this study
Official title: Prospective Evaluation of Symptom Resolution in Acid Versus Non-acid Reflux Disease Following Anti-reflux Surgery.
Gastroesophageal reflux disease (GERD) is a common ailment affecting a significant portion of the US population. With the advent and increased use of esophageal impedance monitoring, both acid and nonacid reflux disease can be better diagnosed and treated. Patients with severe symptoms or symptoms refractory to medical management may be offered anti-reflux surgery for optimal treatment. Though there are a handful of studies evaluating the efficacy of anti-reflux surgery on those patients with acid or non-acid related reflux disease, the comparison between acid and non-acid reflux disease following surgery is lacking. We propose a prospective study comparing clinical outcomes from those patients with acid versus non-acid reflux disease following anti-reflux surgery with the use of validated and disease specific quality of life surveys.
- Conditions
- Non-acid Reflux Disease
- Being tested
- anti-reflux surgery
- Keywords
- Nissen fundoplication, non-acid reflux disease, anti-reflux surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-reflux surgeryProcedure or surgery
Anti-reflux surgery (Laparoscopic Nissen Fundoplication)
| Study group | Role | What they receive |
|---|---|---|
| Normal pH, abnormal Impedance | Active comparator | After 24hr pH-metry and impedance, those patients with normal pH (i.e. DeMeester score <14.7) but with abnormal impedance scores will be offered anti-reflux surgery Receives: Procedure: anti-reflux surgery |
| Abnormal pH | Placebo comparator | After 24hr pH-metry and impedance, those with abnormal pH scores (i.e. DeMeester score >14.7)will be offered anti-reflux surgery Receives: Procedure: anti-reflux surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of anti-reflux surgery
To prospectively evaluate the effectiveness of anti-reflux surgery, as measured by symptom reduction, in the treatment of nonacid reflux disease compared prospectively with acid reflux disease.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startNov 2010
- Primary completion26 Mar 2014
- Study completion26 Mar 2014
Why it stopped: Unable to recruit a sufficient number of subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-acid Reflux DiseaseStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, Portsmouth
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ellie Mentler, MD, Principal investigator, United States Naval Medical Center, Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241149
- Sponsor's protocol ID
- CIP# 10.0090
- Status last verified
- Aug 2025
- First submitted
- 15 Nov 2010
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Symptom Resolution in Acid Versus Non-acid Reflux Disease Following Anti-reflux Surgery.
- ClinicalTrials.gov ID
- NCT01241149
- Acronym / sponsor ID
- CIP# 10.0090
- Conditions
- Non-acid Reflux Disease
- Keywords
- Nissen fundoplication, non-acid reflux disease, anti-reflux surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit a sufficient number of subjects.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- United States Naval Medical Center, PortsmouthUS federal agency
- Study start
- Nov 2010 (actual)
- Primary completion
- 26 Mar 2014 (actual)
- Study completion
- 26 Mar 2014 (actual)
- First posted
- 16 Nov 2010 (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.
Gastroesophageal reflux disease (GERD) is a common ailment affecting a significant portion of the US population. With the advent and increased use of esophageal impedance monitoring, both acid and nonacid reflux disease can be better diagnosed and treated. Patients with severe symptoms or symptoms refractory to medical management may be offered anti-reflux surgery for optimal treatment. Though there are a handful of studies evaluating the efficacy of anti-reflux surgery on those patients with acid or non-acid related reflux disease, the comparison between acid and non-acid reflux disease following surgery is lacking. We propose a prospective study comparing clinical outcomes from those patients with acid versus non-acid reflux disease following anti-reflux surgery with the use of validated and disease specific quality of life surveys.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal pH, abnormal Impedance | Active comparator | Procedure: anti-reflux surgeryAfter 24hr pH-metry and impedance, those patients with normal pH (i.e. DeMeester score <14.7) but with abnormal impedance scores will be offered anti-reflux surgery |
| Abnormal pH | Placebo comparator | Procedure: anti-reflux surgeryAfter 24hr pH-metry and impedance, those with abnormal pH scores (i.e. DeMeester score >14.7)will be offered anti-reflux surgery |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are offered anti-reflux surgical treatment with elevated DeMeester scores or with low (less than 14.7) DeMeester scores, but with positive impedance scores (positive symptom index associated with reflux episodes).
Key exclusion criteria (16 listed)
- • Previous major upper gastrointestinal surgery (includes esophagus, stomach, and duodenum) - previous cholecystectomy (gallbladder removal) is not considered a major upper GI surgery
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 |
|---|---|---|
| anti-reflux surgeryAnti-reflux surgery (Laparoscopic Nissen Fundoplication) | Procedure or surgery | Abnormal pH, Normal pH, abnormal Impedance |
Primary outcome
Effectiveness of anti-reflux surgery
Time frame: 1 year
To prospectively evaluate the effectiveness of anti-reflux surgery, as measured by symptom reduction, in the treatment of nonacid reflux disease compared prospectively with acid reflux disease.
Results and safety
The study was stopped early (reason given: Unable to recruit a sufficient number of subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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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.
Ellie Mentler, MD principal investigator
United States Naval Medical Center, Portsmouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-reflux surgery in people with Non-acid Reflux Disease, run by United States Naval Medical Center, Portsmouth at 1 site 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 1 inclusion and 16 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 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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: Unable to recruit a sufficient number of subjects.). 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?
Effectiveness of anti-reflux surgery (time frame: 1 year). 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 15 Aug 2025.