Clinical trial · Observational
In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter
NCT00737802CI-TRIAL-00037217terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Was not able to recruit the total anticipated number of subjects
Summary
Brief summary (as posted)
The purpose of this study is: * To study the components of the gastroesophageal junction high-pressure zone individually and as a group, by pharmacologically eliminating or accentuating the pressure profile generated by the smooth muscle components. * To differentiate the gastric sling fibers from the clasp fibers based on the spatial orientation of these muscle groups.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barretts Esophagus | — | UNRESOLVED | — |
| GERD | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Normal Control
- description
- Normal control subjects are the participants with no history of GERD, no signs and symptoms of GERD
- label
- GERD Patients
- description
- GERD patients are those with history of GERD, signs and symptoms of GERD and selected signs and symptoms of GERD in the questionnaire.
- label
- Barrett's patients
- description
- Barrett's patients are those participants who in addition to all the qualities of GERD patients have long standing history of GERD and mucosal changes in the esophagus.
Primary outcomes (1)
- measure
- Pressure at the gastric sling and clasp fibers
- timeFrame
- 5 years
- description
- esophageal and gastroesophageal junction Pressure at the gastric sling and clasp fibers
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Inclusion criteria for GERD patients are: * Symptomatic heartburn * Regurgitation * Chest pain or water brash Exclusion Criteria: Exclusion criteria for normal volunteers include: * Medications-Subjects on any medication which could effect the gastroesophageal junction high-pressure zone will be excluded, this includes use of antacids, H2 blockers, proton pump inhibitors, prokinetic agents, erythromycin type antibiotics and anticholinergics. * GI symptoms, conditions and disorders In addition exclusion criteria will include a history of: * Esophagitis * Gastrointestinal symptoms such as abdominal pain * Heartburn * Reflux * Regurgitation * Chest pain * Difficulty swallowing * Pain on swallowing * Dysphagia * Abdominal surgery involving the stomach or esophagus * Nausea or vomiting * Diabetes * Scleroderma * Esophageal motility disorders * Non cardiac chest pain * Achalasia and current pregnancy.
References
Publications (0)
Data not yet available
No reference posted for this study.