AchalasiaNCT02434991
Sensorimotor Dysfunction in Achalasia
A study testing Barostat in people with Achalasia, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to assess the esophageal muscle (swallowing tube) in patients with and without achalasia to further understand and help direct the treatment for patients with achalasia. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Achalasia
- What is being tested?
- Barostat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2018to 14 Aug 2018
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ages 18-90
- Patients with achalasia, defined by an esophageal manometry study consistent with the diagnosis
Who cannot join
- Patients with EGD or esophagram findings suggestive of pseudoachalasia
- Previous history of pneumatic dilation, Heller myotomy, or botulinum toxin injection to the distal esophagus
- Esophageal diameter greater than 6 cm
- Previous history of upper gastrointestinal surgery
- Medical conditions such as severe heart or lung disease that preclude safe performance barostat
- Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This study is being done to assess the esophageal muscle (swallowing tube) in patients with and without achalasia to further understand and help direct the treatment for patients with achalasia.
Read the detailed description
Achalasia is currently defined solely on the basis of esophageal manometry. However, this fails to assess sensory function which may relate more to symptoms such as chest pain and heartburn. To date, the importance of sensory dysfunction in achalasia is poorly understood. The investigators want to define the relationship between esophageal sensory and motor dysfunction and symptoms in achalasia.
Following standard diagnostic evaluation including esophagogastroduodenoscopy (EGD), barium esophagram, and esophageal manometry, symptoms will be assessed utilizing a standardized questionnaire. The subjects will then undergo transoral placement of an esophageal barostat. Following a standard protocol of esophageal distension, esophageal body compliance will be recorded with esophageal body pressure and volume. Mechanosensitivity will then be assessed utilizing a stepwise esophageal distension, with patients reporting symptoms utilizing a Likert scale. Patients will then undergo conventional achalasia treatment with either pneumatic dilation or Heller myotomy at the discretion of the treating gastroenterologist. Thereafter patients will be followed via a standardized phone survey at 3 months, 6 months, 2 years, and 4 years after treatment to assess symptoms and treatment response. Patients will have standard clinical follow ups, including barium esophagram, at 1 year, 3 years, and 5 years following treatment. Outcomes: From 100 new patients with achalasia seen yearly at Mayo, the investigators anticipate recruitment of 40 eligible patients over 12 months and 10 healthy volunteers. The correlation between mechanosensitivity and esophageal body compliance with symptoms such as dysphagia, chest pain, and heartburn will be measured in Types I, II and III achalasia. The association of these parameters with conventional manometrically defined achalasia subtypes will also be measured. Finally, the relationship between sensorimotor dysfunction in achalasia and therapeutic outcomes will be assessed with development of predictive models to assess symptomatic outcome by barostat measurements.
- Conditions
- Achalasia
- Being tested
- Barostat
- Keywords
- trouble swallowing, food sticking, Achalasia
- Medical subject headings
- Esophageal Achalasia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BarostatDevice
Also called Sensorimotor dysfunction
- During this study, the investigators will ask you to fill out questionnaires about your swallowing, chest pain, and heartburn. The investigators hope the patient will answer all of the questions, but patients can skip any questions they do not want to answer. The questionnaires will take about 15 minutes to complete.
- A urine pregnancy test for females of childbearing years.
- Patients will be asked to fast overnight (nothing to eat or drink for 8 hours) prior to the barostat test.
- At this point healthy controls have completed the study.
- Patients with achalasia will then undergo treatment for achalasia at the discretion of the primary clinician managing their case.
- Patients will be contacted to complete a phone survey 3 \& 6 months and 2 \& 4 years after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Barostat | Experimental | The barostat (a thin tube, with a deflated balloon attached at the end) will be placed through your mouth down your esophagus (swallowing tube) to where your stomach and esophagus meet. The 10-cm long balloon will then be inflated with step by step pressure increases of 4mmHg for 30 seconds each to a maximum pressure of 50mmHg. The patient will rate discomfort during each step of inflation Receives: Device: Barostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of discomfort during barostat
During each distention, patients would report presence of discomfort as: 0) none 1) sensation without discomfort 2) mild discomfort 3) moderate discomfort 4) pain. This scale has been utilized in previous studies assessing esophageal mechanosensitivity.
Measured: 20 minutes
Secondary outcomes (1)
symptoms (followup phone survey)
Measuring symptoms (dysphagia, regurgitation, chest pain, nocturnal cough) with modified Eckardt Score 0 None 1 occasional 2 daily
None Occasional Daily
Measured: 3, 6 months, 2, 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMar 2018 (estimated)
- Primary completion14 Aug 2018
- Study completion14 Aug 2018
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karthik Ravi, M.D., Mayo Clinic
- Investigators
- Karthik Ravi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434991
- Sponsor's protocol ID
- 14-009073
- Status last verified
- Aug 2018
- First submitted
- 6 Apr 2015
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorimotor Dysfunction in Achalasia
- ClinicalTrials.gov ID
- NCT02434991
- Acronym / sponsor ID
- 14-009073
- Conditions
- Achalasia
- Keywords
- trouble swallowing, food sticking, Achalasia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 6 May 2015 (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.
This study is being done to assess the esophageal muscle (swallowing tube) in patients with and without achalasia to further understand and help direct the treatment for patients with achalasia.
Detailed description
Achalasia is currently defined solely on the basis of esophageal manometry. However, this fails to assess sensory function which may relate more to symptoms such as chest pain and heartburn. To date, the importance of sensory dysfunction in achalasia is poorly understood. The investigators want to define the relationship between esophageal sensory and motor dysfunction and symptoms in achalasia.
Following standard diagnostic evaluation including esophagogastroduodenoscopy (EGD), barium esophagram, and esophageal manometry, symptoms will be assessed utilizing a standardized questionnaire. The subjects will then undergo transoral placement of an esophageal barostat. Following a standard protocol of esophageal distension, esophageal body compliance will be recorded with esophageal body pressure and volume. Mechanosensitivity will then be assessed utilizing a stepwise esophageal distension, with patients reporting symptoms utilizing a Likert scale. Patients will then undergo conventional achalasia treatment with either pneumatic dilation or Heller myotomy at the discretion of the treating gastroenterologist. Thereafter patients will be followed via a standardized phone survey at 3 months, 6 months, 2 years, and 4 years after treatment to assess symptoms and treatment response. Patients will have standard clinical follow ups, including barium esophagram, at 1 year, 3 years, and 5 years following treatment. Outcomes: From 100 new patients with achalasia seen yearly at Mayo, the investigators anticipate recruitment of 40 eligible patients over 12 months and 10 healthy volunteers. The correlation between mechanosensitivity and esophageal body compliance with symptoms such as dysphagia, chest pain, and heartburn will be measured in Types I, II and III achalasia. The association of these parameters with conventional manometrically defined achalasia subtypes will also be measured. Finally, the relationship between sensorimotor dysfunction in achalasia and therapeutic outcomes will be assessed with development of predictive models to assess symptomatic outcome by barostat measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Barostat | Experimental | Device: BarostatThe barostat (a thin tube, with a deflated balloon attached at the end) will be placed through your mouth down your esophagus (swallowing tube) to where your stomach and esophagus meet. The 10-cm long balloon will then be inflated with step by step pressure increases of 4mmHg for 30 seconds each to a maximum pressure of 50mmHg. The patient will rate discomfort during each step of inflation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ages 18-90
- Patients with achalasia, defined by an esophageal manometry study consistent with the diagnosis
Key exclusion criteria (6 listed)
- Patients with EGD or esophagram findings suggestive of pseudoachalasia
- Previous history of pneumatic dilation, Heller myotomy, or botulinum toxin injection to the distal esophagus
- Esophageal diameter greater than 6 cm
- Previous history of upper gastrointestinal surgery
- Medical conditions such as severe heart or lung disease that preclude safe performance barostat
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 |
|---|---|---|
| BarostatAlso: Sensorimotor dysfunction* During this study, the investigators will ask you to fill out questionnaires about your swallowing, chest pain, and heartburn. The investigators hope the patient will answer all of the questions, but patients can skip any questions they do not want to answer. The questionnaires will take about 15 minutes to complete. * A urine pregnancy test for females of childbearing years. * Patients will be asked to fast overnight (nothing to eat or drink for 8 hours) prior to the barostat test. * At this point healthy controls have completed the study. * Patients with achalasia will then undergo treatment for achalasia at the discretion of the primary clinician managing their case. * Patients will be contacted to complete a phone survey 3 \& 6 months and 2 \& 4 years after treatment. | Device | Barostat |
Primary outcome
Presence of discomfort during barostat
Time frame: 20 minutes
During each distention, patients would report presence of discomfort as: 0) none 1) sensation without discomfort 2) mild discomfort 3) moderate discomfort 4) pain. This scale has been utilized in previous studies assessing esophageal mechanosensitivity.
1 secondary outcome
symptoms (followup phone survey)
Time frame: 3, 6 months, 2, 4 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
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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.
Karthik Ravi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barostat in people with Achalasia, run by Mayo Clinic 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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 16 Aug 2018. 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. 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 withdrawn before enrolling participants, so there are no results.
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?
Presence of discomfort during barostat (time frame: 20 minutes). 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 16 Aug 2018.