Study Stopped
Study design revision
Establishing a Correlation Between HRM and UGI MM Studies
MMvsMANO
Correlation of High Resolution Manometry and Upper Gastrointestinal Marshmallow Study in Preoperative Esophageal Motility Assessment
Sponsor study identifier
observational
204
1 country
1
Study Start
August 24, 2022
Actual (reported)Primary Completion
January 28, 2025
Actual (reported)Study Completion
January 28, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 28, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 24, 2022
Actual (reported)March 11, 2024
Actual (reported)March 18, 2024
Actual (reported)January 28, 2025
Actual (reported)January 28, 2025
Actual (reported)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.
June 2021 -July 2025
Patients undergoing preoperative testing for surgical intervention involving manipulation of the upper gastrointestinal tract.
Lexington Health Incorporated
West Columbia, South Carolina, 29169, United States
Yadlapati R. High-resolution esophageal manometry: interpretation in clinical practice. Curr Opin Gastroenterol. 2017 Jul;33(4):301-309. doi: 10.1097/MOG.0000000000000369.
FalcAo 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.
Marc Antonetti, MD
Lexington Health Incorporated
204 participants (actual enrollment reported by the registry).
First Submitted
March 11, 2024
First Posted
March 18, 2024
Study Start
August 24, 2022
Actual (reported)Monopolar and Bipolar Current RFA Knife in POEM
Contact the study team to confirm eligibility.
Musella 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.
Primary Completion
January 28, 2025
Actual (reported)Study Completion
January 28, 2025
Actual (reported)Last Updated
April 17, 2025
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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