Esophageal Motility DisordersMMvsMANONCT06314893
Establishing a Correlation Between HRM and UGI MM Studies
An observational study of Esophageal Motility Disorders, run by Lexington Health Incorporated at 1 site in United States.
Trial summary
A retrospective and prospective cohort, quantitative data collection with the goal of comparing preoperative High Resolution Manometry HRM results to Upper Gastrointestinal Marshmallow ,UGI MM results, in patients undergoing preoperative esophageal motility assessments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Motility Disorders
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2022to 28 Jan 2025
- Phase
- Observational
- 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
Study population: Patients undergoing preoperative testing for surgical intervention involving manipulation of the upper gastrointestinal tract.
Who may be able to join
- Preoperative patients who have undergone both HRM and UGI MM assessments as part of their preoperative plan of care.
- Patients who have had surgical procedures involving the upper GI tract and immediate surrounding structures after completing HRM and UGI MM assessments preoperatively
- Adults age 18 and older
Who cannot join
- Patients who continued taking narcotics, calcium channel blockers, nitrates or promotility medications the day of the HRM test, as these medications could falsely relax or hyper stimulate esophageal structures.
- Patients with a past surgical history that includes Heller myotomy, peroralesophageal myotomy, botulinum injections, pneumatic dilations or gastric fundoplication
Trial locations and contacts
1 site in 1 country.
United States1 site
Lexington Health Incorporated
West Columbia, South Carolina, 29169
About this study
Official title: Correlation of High Resolution Manometry and Upper Gastrointestinal Marshmallow Study in Preoperative Esophageal Motility Assessment
A retrospective and prospective cohort, quantitative data collection with the goal of comparing preoperative High Resolution Manometry HRM results to Upper Gastrointestinal Marshmallow ,UGI MM results, in patients undergoing preoperative esophageal motility assessments. The aim of this study is to establish a correlation between HRM and UGI MM in order to create a clinically supported gold standard measurement for preoperative esophageal motility assessment.
Read the detailed description
Identifying esophageal motility disorders prior to surgical intervention is imperative when determining the procedural route that will produce the greatest positive patient outcome and reduce postoperative sequelae related to preoperative conditions. Possible disparities have been identified between HRM and UGI MM assessment results. Identifying testing variables and standards that could impact the obtained results will allow providers the ability to create a more customized plan of care and increase outcome predictability. Therefore, examining HRM and UGI MM level of agreement is essential to providing the best evidence-based practice care and meeting the unique needs of individual patients.
Currently, HRM results are noted as the standard benchmark for adequate assessment of esophageal motility function and disorders. Esophageal manometry testing provides a means to determine if the esophagus is functioning properly through a series of wet swallows. As a patient swallows, the esophagus contracts in a orderly sequence to push the swallowed contents to the stomach. Once the contents enter the stomach, the Lower Esophageal Sphincter, LES closes to prevent backflow or reflux of the stomach contents into the esophagus. Assessment of motility and sphincter function is vital prior to any surgical intervention that involves manipulation of the gastroesophageal junction,GEJ or surrounding structures. Inaccurate surgical manipulation can cause undesired pressure changes and alterations in normal peristalsis within the esophageal body. Any impairment to esophageal motility can compromise clearance and sphincter function, leading to adverse outcomes such as the development of intestinal metaplasia due to prolonged exposure of the mucosa to gastric acid
1.Patient Identification
- Patients undergoing esophageal motility evaluation prior to surgical intervention. Surgical interventions involve manipulation of the upper gastrointestinal tract and immediate surrounding structures.
- Patients undergoing procedures where the standard of care routinely includes preoperative motility assessment. These procedures include fundoplication procedures, open, laparoscopic and endoscopic and gastric sleeve or bypass candidates.
- Conditions
- Esophageal Motility Disorders
- Keywords
- GI tract
- Medical subject headings
- Esophageal Motility Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the correlation between HRM and UGI MM assessments among preoperative candidates will provide an evidenced based evaluation strategy for establishing procedural candidacy and predicting postoperative outcomes.
Measured: June 2021 -July 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start24 Aug 2022
- Primary completion28 Jan 2025
- Study completion28 Jan 2025
Why it stopped: Study design revision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal Motility DisordersStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexington Health Incorporated
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Antonetti, MD, Lexington Health Incorporated
- Investigators
- Marc Antonetti, MD, Principal investigator, Lexington Health Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314893
- Sponsor's protocol ID
- LMCII2022-001
- Acronym
- MMvsMANO
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yadlapati R. High-resolution esophageal manometry: interpretation in clinical practice. Curr Opin Gastroenterol. 2017 Jul;33(4):301-309. doi: 10.1097/MOG.0000000000000369.
PubMed 28426462FalcAo AM, Nasi A, Szachnowicz S, Santa-Cruz F, Seguro FCBC, Sena BF, Duarte A, Sallum RA, Cecconello I. Does the nissen fundoplication procedure improve esophageal dysmotility in patients with barrett's esophagus? Rev Col Bras Cir. 2020 Nov 30;47:e20202637. doi: 10.1590/0100-6991e-20202637. eCollection 2020. English, Portuguese.
PubMed 33263652Musella M, Vitiello A, Berardi G, Velotti N, Pesce M, Sarnelli G. Evaluation of reflux following sleeve gastrectomy and one anastomosis gastric bypass: 1-year results from a randomized open-label controlled trial. Surg Endosc. 2021 Dec;35(12):6777-6785. doi: 10.1007/s00464-020-08182-3. Epub 2020 Dec 2.
PubMed 33269429
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of High Resolution Manometry and Upper Gastrointestinal Marshmallow Study in Preoperative Esophageal Motility Assessment
- ClinicalTrials.gov ID
- NCT06314893
- Acronym / sponsor ID
- MMvsMANO / LMCII2022-001
- Conditions
- Esophageal Motility Disorders
- Keywords
- GI tract
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study design revision
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Lexington Health IncorporatedUniversity, hospital or other
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 28 Jan 2025 (actual)
- First posted
- 18 Mar 2024 (actual)
- 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.
A retrospective and prospective cohort, quantitative data collection with the goal of comparing preoperative High Resolution Manometry HRM results to Upper Gastrointestinal Marshmallow ,UGI MM results, in patients undergoing preoperative esophageal motility assessments. The aim of this study is to establish a correlation between HRM and UGI MM in order to create a clinically supported gold standard measurement for preoperative esophageal motility assessment.
Detailed description
Identifying esophageal motility disorders prior to surgical intervention is imperative when determining the procedural route that will produce the greatest positive patient outcome and reduce postoperative sequelae related to preoperative conditions. Possible disparities have been identified between HRM and UGI MM assessment results. Identifying testing variables and standards that could impact the obtained results will allow providers the ability to create a more customized plan of care and increase outcome predictability. Therefore, examining HRM and UGI MM level of agreement is essential to providing the best evidence-based practice care and meeting the unique needs of individual patients.
Currently, HRM results are noted as the standard benchmark for adequate assessment of esophageal motility function and disorders. Esophageal manometry testing provides a means to determine if the esophagus is functioning properly through a series of wet swallows. As a patient swallows, the esophagus contracts in a orderly sequence to push the swallowed contents to the stomach. Once the contents enter the stomach, the Lower Esophageal Sphincter, LES closes to prevent backflow or reflux of the stomach contents into the esophagus. Assessment of motility and sphincter function is vital prior to any surgical intervention that involves manipulation of the gastroesophageal junction,GEJ or surrounding structures. Inaccurate surgical manipulation can cause undesired pressure changes and alterations in normal peristalsis within the esophageal body. Any impairment to esophageal motility can compromise clearance and sphincter function, leading to adverse outcomes such as the development of intestinal metaplasia due to prolonged exposure of the mucosa to gastric acid
1.Patient Identification
- Patients undergoing esophageal motility evaluation prior to surgical intervention. Surgical interventions involve manipulation of the upper gastrointestinal tract and immediate surrounding structures.
- Patients undergoing procedures where the standard of care routinely includes preoperative motility assessment. These procedures include fundoplication procedures, open, laparoscopic and endoscopic and gastric sleeve or bypass candidates.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing preoperative testing for surgical intervention involving manipulation of the upper gastrointestinal tract.
Key inclusion criteria (3 listed)
- Preoperative patients who have undergone both HRM and UGI MM assessments as part of their preoperative plan of care.
- Patients who have had surgical procedures involving the upper GI tract and immediate surrounding structures after completing HRM and UGI MM assessments preoperatively
- Adults age 18 and older
Key exclusion criteria (2 listed)
- Patients who continued taking narcotics, calcium channel blockers, nitrates or promotility medications the day of the HRM test, as these medications could falsely relax or hyper stimulate esophageal structures.
- Patients with a past surgical history that includes Heller myotomy, peroralesophageal myotomy, botulinum injections, pneumatic dilations or gastric fundoplication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determining the correlation between HRM and UGI MM assessments among preoperative candidates will provide an evidenced based evaluation strategy for establishing procedural candidacy and predicting postoperative outcomes.
Time frame: June 2021 -July 2025
Results and safety
The study was stopped early (reason given: Study design revision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Background: PubMed 28426462Yadlapati R. High-resolution esophageal manometry: interpretation in clinical practice. Curr Opin Gastroenterol. 2017 Jul;33(4):301-309. doi: 10.1097/MOG.0000000000000369.
- Background: PubMed 33263652FalcAo AM, Nasi A, Szachnowicz S, Santa-Cruz F, Seguro FCBC, Sena BF, Duarte A, Sallum RA, Cecconello I. Does the nissen fundoplication procedure improve esophageal dysmotility in patients with barrett's esophagus? Rev Col Bras Cir. 2020 Nov 30;47:e20202637. doi: 10.1590/0100-6991e-20202637. eCollection 2020. English, Portuguese.
- Background: PubMed 33269429Musella M, Vitiello A, Berardi G, Velotti N, Pesce M, Sarnelli G. Evaluation of reflux following sleeve gastrectomy and one anastomosis gastric bypass: 1-year results from a randomized open-label controlled trial. Surg Endosc. 2021 Dec;35(12):6777-6785. doi: 10.1007/s00464-020-08182-3. Epub 2020 Dec 2.
- Esophageal ManometryLink provided by the sponsor.
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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.
Marc Antonetti, MD principal investigator
Lexington Health Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Motility Disorders, run by Lexington Health Incorporated 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 2 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 17 Apr 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. 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: Study design revision). 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?
Determining the correlation between HRM and UGI MM assessments among preoperative candidates will provide an evidenced based evaluation strategy for establishing procedural candidacy and predicting postoperative outcomes. (time frame: June 2021 -July 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06314893, which also lists 3 linked publications.
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 17 Apr 2025.