Comparison of Esophageal and Anorectal Manometry Catheters

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to compare the accuracy of esophageal and anorectal manometric pressure measurements using a newly developed air filled balloon catheter with present standard solid state esophageal and anorectal catheters, respectively.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Connected Catheter- Safety and Effectiveness Study

NCT03843073

Urinary Retention Neurogenic Bladder Urologic Diseases

TERMINATED NA

Comparison of Air Charged Catheters With Water Filled Catheters for Urodynamic Study

NCT02030340

Incontinence

UNKNOWN

Anatomical and Functional Outcomes of Perigee and Apogee Mesh in Total Pelvic Floor Reconstruction Versus Gynecare Prolift

NCT03070873

Pelvic Organ Prolapse

COMPLETED NA

Point-of-care Anorectal Testing to Predict Outcomes With Biofeedback Therapy: Clinical Trial

NCT04159350

Constipation

COMPLETED NA

Measurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing

NCT03456089

Urinary Bladder, Neurogenic Urodynamics

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Twenty subjects with abnormal esophageal motility (5 subjects each with achalasia, nutcracker esophagus, scleroderma, diffuse esophageal spasm or hypertensive LES) previously referred for clinical esophageal motility testing will be contacted. These twenty subjects must have previously undergone esophageal manometry testing using the standard clinical protocol at the University of Utah motility with solid state manometry catheters. After obtaining informed consent, these twenty subjects will undergo the esophageal manometry using air-filled balloon catheters per the standard clinical protocol. Following the repeat procedure a short one-page questionnaire will be completed by the subject and the motility nurse.

Five subjects with the diagnosis of incontinence previously referred for clinical anorectal motility testing will be contacted. These five subjects must have previously undergone anorectal manometry using the standard clinical protocol for an anorectal manometry study with water perfused anorectal manometry catheters. After obtaining informed consent, these five subjects will undergo the anorectal manometry using air-filled balloon catheters per the standard clinical protocol. Following the repeat procedure a short one-page questionnaire will be completed by the subject and the motility nurse.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Achalasia Nutcracker Esophagus Scleroderma Esophageal Spasm Fecal Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2

Solid state catheter

Group Type ACTIVE_COMPARATOR

Solid state catheter

Intervention Type DEVICE

The standardly used solid state catheter will be tested against the new air filled balloon catheter

A

Group Type EXPERIMENTAL

Air filled balloon catheter

Intervention Type DEVICE

The new air filled balloon catheter will be tested against the solid state catheter

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Air filled balloon catheter

The new air filled balloon catheter will be tested against the solid state catheter

Intervention Type DEVICE

Solid state catheter

The standardly used solid state catheter will be tested against the new air filled balloon catheter

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Clinical innovations manometry catheter

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Between the ages of 18-80 years old
* Ability to give informed consent
* No significant medical conditions
* Abnormal esophageal motility
* Abnormal anorectal motility