Motility DisorderPhase 1HRMNCT01773330
High Resolution Manometry for Swallowing
A Phase 1 study testing esophageal manometry, Gatorade and Supine position in people with Motility Disorder, run by University of Florida at 1 site in United States.
Trial summary
This study is using a new technology known as high resolution manometry which is used to evaluate patients that have trouble swallowing or have chest pain that is not related to the heart. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Motility Disorder
- What is being tested?
- esophageal manometry, Gatorade and Supine position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2015
- Phase
- Phase 1
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80
- Healthy Volunteer
- No clinical evidence of dysphagia
Who cannot join
- History of prior dysphagia
- Prior esophageal or gastric dysmotility secondary to systemic conditions (scleroderma or diabetes mellitus)
- Known gastrointestinal malignancy
- Use of medications known to affect esophageal or gastric motility (e.g. anticholinergics, opiates, calcium channel blockers)
- Previous esophageal or gastric surgery
- Significant cardiac or respiratory disease
- Pregnancy (a pregnancy test will be performed in women of child-bearing potential)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Resolution Manometry: Optimizing the Swallow Protocol
This study is using a new technology known as high resolution manometry which is used to evaluate patients that have trouble swallowing or have chest pain that is not related to the heart. The investigator wants to learn how the different positions of the body, in a lying position, semi-recumbent, sitting position or standing up, and the amount of liquid affects the outcome of the test. This will help the investigator to determine a standardized protocol for patients with trouble swallowing.
Read the detailed description
The esophageal manometry will be performed in the motility lab at the Shands Endoscopy Center by passing a small tube into the patients nose, down the food pipe and into the stomach. The participants will be instructed to swallow a determined volume of Gatorade,depending on the protocol being followed. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up. When the esophageal manometry is finished, the tube is removed and participation in this study is complete.
- Conditions
- Motility Disorder
- Being tested
- esophageal manometry, Gatorade, Supine position, Semi-recumbent position, Sitting
- Keywords
- high resolution manometry, provocative swallow, impedence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophageal manometryProcedure or surgery
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed.There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
GatoradeDietary supplement
The patient will be given Gatorade to drink at various times during the study.
Supine positionOther
Also called Semi-recumbent, Sitting, Standing up
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
Semi-recumbent positionOther
Also called Supine position, Sitting position, Standing up
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
SittingProcedure or surgery
Also called Supine, Semi-recumbent, Standing
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
StandingProcedure or surgery
Also called Supine position, Semi-recumbent position, Sitting position
Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
| Study group | Role | What they receive |
|---|---|---|
| esophageal manometry | Experimental | Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position. Receives: Procedure: esophageal manometry; Dietary Supplement: Gatorade; Other: Supine position; Other: Semi-recumbent position; Procedure: Sitting; Procedure: Standing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal values for HRM while the patient is in the most physiologic position to stimulate normal eating habits.
The patient is instructed to swallow a determined volume of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up.
Measured: up to 1 hour
Secondary outcomes (4)
Normal HRM values for a 200 ml provocative swallow.
The patient is instructed to swallow 200 ml of Gatorade in the sitting position.
Measured: up to 5 minutes
Bolus clearance for each swallow with impedance.
The patient is instructed to swallow a determined volume of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up.
Measured: up to 1 hour
Normal size and diameter of esophagus and esophageal distension on a regular basis with the provocative swallow and impedance.
The patient is instructed to swallow different amounts of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up.
Measured: up to 1 hour
Standardization of the testing protocol for HRM and the reliability of volume and number of swallows.
The patient is instructed to swallow different amounts of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up.
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Study has been halted per PI and IRB recommendation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motility DisorderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qing Zhang, M.D., Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773330
- Sponsor's protocol ID
- 502-2012
- Acronym
- HRM
- Status last verified
- Jan 2015
- First submitted
- 11 Jan 2013
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Manometry: Optimizing the Swallow Protocol
- ClinicalTrials.gov ID
- NCT01773330
- Acronym / sponsor ID
- HRM / 502-2012
- Conditions
- Motility Disorder
- Keywords
- high resolution manometry, provocative swallow, impedence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been halted per PI and IRB recommendation
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Jan 2013 (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 using a new technology known as high resolution manometry which is used to evaluate patients that have trouble swallowing or have chest pain that is not related to the heart. The investigator wants to learn how the different positions of the body, in a lying position, semi-recumbent, sitting position or standing up, and the amount of liquid affects the outcome of the test. This will help the investigator to determine a standardized protocol for patients with trouble swallowing.
Detailed description
The esophageal manometry will be performed in the motility lab at the Shands Endoscopy Center by passing a small tube into the patients nose, down the food pipe and into the stomach. The participants will be instructed to swallow a determined volume of Gatorade,depending on the protocol being followed. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up. When the esophageal manometry is finished, the tube is removed and participation in this study is complete.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| esophageal manometry | Experimental | Procedure: esophageal manometry, Dietary Supplement: Gatorade, Other: Supine position, Other: Semi-recumbent position, Procedure: Sitting, Procedure: StandingEsophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80
- Healthy Volunteer
- No clinical evidence of dysphagia
Key exclusion criteria (7 listed)
- History of prior dysphagia
- Prior esophageal or gastric dysmotility secondary to systemic conditions (scleroderma or diabetes mellitus)
- Known gastrointestinal malignancy
- Use of medications known to affect esophageal or gastric motility (e.g. anticholinergics, opiates, calcium channel blockers)
- Previous esophageal or gastric 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 |
|---|---|---|
| esophageal manometryEsophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed.There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position. | Procedure or surgery | esophageal manometry |
| GatoradeThe patient will be given Gatorade to drink at various times during the study. | Dietary supplement | esophageal manometry |
| Supine positionAlso: Semi-recumbent, Sitting, Standing upEsophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position. | Other | esophageal manometry |
| Semi-recumbent positionAlso: Supine position, Sitting position, Standing upEsophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position. | Other | esophageal manometry |
| SittingAlso: Supine, Semi-recumbent, StandingEsophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position. | Procedure or surgery | esophageal manometry |
| StandingAlso: Supine position, Semi-recumbent position, Sitting positionEsophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position. | Procedure or surgery | esophageal manometry |
Primary outcome
Normal values for HRM while the patient is in the most physiologic position to stimulate normal eating habits.
Time frame: up to 1 hour
The patient is instructed to swallow a determined volume of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up.
4 secondary outcomes
Normal HRM values for a 200 ml provocative swallow.
Time frame: up to 5 minutes
Bolus clearance for each swallow with impedance.
Time frame: up to 1 hour
Normal size and diameter of esophagus and esophageal distension on a regular basis with the provocative swallow and impedance.
Time frame: up to 1 hour
Standardization of the testing protocol for HRM and the reliability of volume and number of swallows.
Time frame: up to 1 hour
Results and safety
The study was stopped early (reason given: Study has been halted per PI and IRB recommendation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
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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.
Qing Zhang, M.D., Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing esophageal manometry, Gatorade and Supine position in people with Motility Disorder, run by University of Florida 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 3 inclusion and 7 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 26 Jan 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study has been halted per PI and IRB recommendation). 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?
Normal values for HRM while the patient is in the most physiologic position to stimulate normal eating habits. (time frame: up to 1 hour). 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 26 Jan 2015.