Trial · NCT07893457
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Esophageal Acid Exposure Time During 96-Hour Wireless pH Monitoring | During the 96-hour wireless pH monitoring period, completed within 40 days after enrollment. | Percentage of total analyzable wireless pH recording time during which distal esophageal pH is less than 4. The value is calculated as the total duration with pH less than 4 divided by the total analyzable recording duration, multiplied by 100. One overall percentage is calculated for each participant across the monitoring period. Higher percentages indicate greater esophageal acid exposure. |
| Secondary | Number of Days With Abnormal Esophageal Acid Exposure During 96-Hour Wireless pH Monitoring | During the 96-hour wireless pH monitoring period, completed within 40 days after enrollment. | Number of interpretable 24-hour recording periods during which esophageal acid exposure time is greater than 6%. Acid exposure time is the percentage of analyzable recording time with distal esophageal pH less than 4. The outcome is a single count of abnormal recording days for each participant. |
| Secondary | Composite DeMeester Score During Wireless pH Monitoring | During the 96-hour wireless pH monitoring period, completed within 40 days after enrollment. | Composite DeMeester score calculated from the analyzable wireless esophageal pH recording. This outcome reports a single composite score for each participant. Higher scores indicate greater esophageal acid reflux burden. |
| Secondary | Esophagogastric Junction Distensibility Index Measured by Functional Lumen Imaging Probe | At the functional lumen imaging probe assessment, performed within 40 days after enrollment. | Esophagogastric junction distensibility index, expressed in square millimeters per millimeter of mercury (mm²/mmHg), measured using the functional lumen imaging probe at a balloon fill volume of 60 mL when intraballoon pressure is greater than 15 mmHg. Higher values indicate greater esophagogastric junction distensibility. |
| Secondary | Maximum Esophagogastric Junction Diameter Measured by Functional Lumen Imaging Probe | At the functional lumen imaging probe assessment, performed within 40 days after enrollment. | Maximum esophagogastric junction diameter, expressed in millimeters, measured using the functional lumen imaging probe. The reported value is the larger of the maximum diameters obtained at balloon fill volumes of 60 mL and 70 mL, yielding one maximum diameter for each participant. |
| Secondary | Resting Lower Esophageal Sphincter Pressure Measured by High-Resolution Manometry | At the high-resolution manometry assessment, performed within 40 days after enrollment. | Resting lower esophageal sphincter pressure, expressed in millimeters of mercury (mmHg), measured using high-resolution esophageal manometry. |
| Secondary | Integrated Relaxation Pressure Measured by High-Resolution Manometry | At the high-resolution manometry assessment, performed within 40 days after enrollment. | Integrated relaxation pressure, expressed in millimeters of mercury (mmHg), measured during standardized water swallows using high-resolution esophageal manometry. |
| Secondary | Mean Proximal Intragastric Pressure Before Seated Swallows | At the high-resolution manometry assessment, performed within 40 days after enrollment. | Mean proximal intragastric pressure during the preswallow interval of seated swallows, expressed in millimeters of mercury (mmHg). Pressure is measured using high-resolution manometry at a location 1 to 3 cm distal to the manometrically identified esophagogastric junction. |
| Secondary | Mean Proximal Intragastric Pressure During Swallow-Induced Esophagogastric Junction Opening | At the high-resolution manometry assessment, performed within 40 days after enrollment. | Mean proximal intragastric pressure during swallow-induced esophagogastric junction opening in the seated position, expressed in millimeters of mercury (mmHg). Pressure is measured using high-resolution manometry at a location 1 to 3 cm distal to the manometrically identified esophagogastric junction. |
| Secondary | Mean Proximal Intragastric Pressure Immediately After Swallow-Induced Esophagogastric Junction Closure | At the high-resolution manometry assessment, performed within 40 days after enrollment. | Mean proximal intragastric pressure immediately after esophagogastric junction closure following seated swallows, expressed in millimeters of mercury (mmHg). Pressure is measured using high-resolution manometry at a location 1 to 3 cm distal to the manometrically identified esophagogastric junction. |
| Secondary | Change From Baseline to Day 7 in Gastroesophageal Reflux Disease Health-Related Quality of Life Total Score | Baseline and Day 7. | Change in the Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) total score, calculated as the Day 7 score minus the baseline score. The 15 scored items are each rated from 0 to 5 and summed to produce a total score ranging from 0 to 75. Higher total scores indicate greater symptom burden and worse disease-related quality of life. Negative change values indicate reduced symptom burden. |
| Secondary | Change From Baseline to Day 7 in Brief Esophageal Dysphagia Questionnaire Total Score | Baseline and Day 7. | Change in the Brief Esophageal Dysphagia Questionnaire (BEDQ) total score, calculated as the Day 7 score minus the baseline score. The total is the sum of eight symptom-frequency and symptom-severity items, each scored from 0 to 5, and ranges from 0 to 40. The two food-impaction items are not included in the total score. Higher total scores indicate greater dysphagia symptom burden. Negative change values indicate reduced symptom burden. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07893457/registered