Mucosal Impedance Balloon in Diagnosis and Treatment of Eosinophilic Esophagitis (EoE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02995395 |
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Recruitment Status :
Completed
First Posted : December 16, 2016
Last Update Posted : February 3, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Eosinophilic Esophagitis Healthy | Device: Mucosal Impedance Balloon catheter |
The standard diagnostic evaluation for EoE includes upper endoscopy with esophageal biopsies. Recently we completed the study "Mucosal impedance in eosinophilic esophagitis and the effect of treatment" using a new technology allowing for direct assessment of mucosal impedance at the time of routine upper endoscopy to assess esophageal integrity and disease activity and alevate the need for biopsies.
For this study, Sandhill Scientific has customized a Mucosal Impedance balloon (MI) assembly to provide precise measurements over a broad area of esophageal epithelium, while eliminating the fluids and spanning across a 10 mm luminal area using the same direct assessment as the mucosal impedance at the time of routine upper endoscopy.
| Study Type : | Observational |
| Actual Enrollment : | 28 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | The Role of the Mucosal Impedance Balloon in the Diagnosis and Treatment Eosinophilic Esophagitis |
| Actual Study Start Date : | October 1, 2017 |
| Actual Primary Completion Date : | August 31, 2019 |
| Actual Study Completion Date : | August 31, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Mucosal Impedance Balloon catheter
At the conclusion of the endoscopy, all fluids will be aspirated from the esophagus. The endoscope will then be left in place in the mid-esophagus and a custom Mucosal Impedance (MI) balloon assembly four axial arrays of 10 sensors (total of 40 sensors) will be positioned along the esophageal mucosal wall under direct visualization to directly measure MI at uniform intervals. Once in place, impedance readings will be recorded for a total of 2 minutes. At this point both the endoscope and impedance catheter will be withdrawn simultaneously.
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Device: Mucosal Impedance Balloon catheter
During the clinical endoscopy (a standard procedure that allows your doctor to look at the inside of your swallowing tube), the 2 mm catheter (tiny tube), called an Intraluminal Impedance Balloon, will be passed through the channel of the standard endoscope. o The catheter (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) for two minutes, readings from the catheter will be recorded. Other Name: Impedance balloon testing |
- Diminished mucosal impedance in patients with Eosinophilic Esophagitis [ Time Frame: 1 year ]Patient with eosinophilic esophagitis have diminished mucosal impedance, reflecting increased permeability to allergens occurring in the esophagus. The impedance measurements are also variable throughout the esophageal mucosa reflecting the patchy histology of eosinophilic esophagitis.
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Inclusion criteria:
- Adults ages 18-90 undergoing clinically indicated upper endoscopy
- Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field on esophageal biopsy despite at least 6 weeks of twice daily proton pump inhibitor therapy
- Patients undergoing clinically indicated upper endoscopy for indications other than dysphagia or GERD with normal appearing esophageal mucosa.
Exclusion criteria:
- Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy
- Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
- Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995395
| United States, Minnesota | |
| Mayo Clinic in Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | David A Katzka | Mayo Clinic |
| Responsible Party: | David A. Katzka, Principal Investigator, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT02995395 |
| Other Study ID Numbers: |
16-005863 |
| First Posted: | December 16, 2016 Key Record Dates |
| Last Update Posted: | February 3, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Esophagitis Eosinophilic Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |
Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |