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Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility

Primary Purpose

Gastroparesis, Dyspepsia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetically Controlled Capsule Endoscopy
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroparesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

Must meet one of the following categories:

  1. Gastroparesis

    Meets diagnostic criteria for gastroparesis:

    1. Evidence of delayed gastric emptying documented with a standard 2 hour or 4 hour gastric emptying scintigraphy exam
    2. Absence of mechanical obstruction
    3. Exhibits cardinal symptoms of early satiety, post-prandial fullness, nausea, vomiting, bloating, and upper abdominal pain

    Gastrointestinal cardinal symptom index (GCSI) score > 0 (i.e., the presence of at least mild severity of >1 of 3 symptoms of nausea/vomiting, postprandial fullness/early satiety, and/or bloating).

  2. Functional Dyspepsia

    Meets Rome IV diagnostic criteria for functional dyspepsia:

    1. Criteria fulfilled for the last 3 months with symptom onset at least six months prior to diagnosis
    2. No evidence of organic, systemic, or metabolic disease that is likely to explain the symptoms on routine investigations (including at upper endoscopy)
    3. Meet criteria for Epigastric pain syndrome and/or Postprandial distress syndrome

    Epigastric Pain Syndrome At least 1 of the following symptoms at least 1 day per week

    1. Bothersome epigastric pain
    2. Bothersome epigastric burning

    Postprandial Distress Syndrome At least 1 of the following symptoms at least 3 days per week

    1. Bothersome postprandial fullness
    2. Bothersome early satiation
  3. G-POEM

    1. The G-POEM procedure must have been performed at least 4 weeks prior to screening.
    2. GCSI score is < 3 which correlates to mild or less symptom severity.
  4. Controls

None of the above conditions

Exclusion Criteria:

  1. Another active disorder or treatment which could explain or contribute to symptoms in the opinion of the Investigator (including but not limited to gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics).
  2. Gastrectomy, fundoplication, vagotomy, bariatric surgery, post-surgical cause of gastroparesis, or gastric stimulation device surgically implanted within the last year. Prior G-POEM procedure for gastroparesis is allowed for the group of post-G-POEM study subjects.
  3. Dysphagia, swallowing disorder
  4. Suspected bowel obstruction or perforation
  5. Gastric or parenteral feeding within 4 weeks of screening
  6. Pregnancy or nursing
  7. History of an eating disorder within 2 years of screening
  8. Recent history (within six months of screening) of Alcohol Use Disorder or Substance Use Disorder as defined in DSM-5.
  9. Uncontrolled thyroid disease
  10. Unstable cardiac, respiratory, hepatic or renal disease
  11. Evidence of uncontrolled blood glucose (including HbA1C >9 or metabolic crisis in past 60 days).
  12. Use of prohibited medication or medication with anti-nausea, antiemetic, neuromodulating, or prokinetic effect within 2 weeks of the screening visit EXCEPT when administered on a stable daily dosing schedule (stable for at least 1 month prior to the screening visit).
  13. Use of as needed or daily opioids within the past 1 month.
  14. Pyloric injection of neurotoxins (e.g. botulinum type A or B) within 3 months of the Screening visit.
  15. Altered mental status (e.g., hepatic encephalopathy) that limits the ability to swallow a capsule
  16. Expected to have Magnetic Resonance Imaging (MRI) examination within 30 days.
  17. No reliable contact information - no phone, no permanent address.
  18. Pacemaker or ICD
  19. Inability to avoid using the bathroom for urination and/or bowel movements for the duration of the study.
  20. Metal Implant (ie metal hip arthroplasty, surgical mesh, coronary or arterial stent)
  21. Prior bowel surgery
  22. Severe claustrophobia
  23. Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results.

Sites / Locations

  • University of California Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Control

Gastroparesis

Functional Dyspepsia

G-POEM

Arm Description

No diagnosis of gastroparesis, functional dyspepsia, or prior G-POEM

Patients with a diagnosis of gastroparesis meeting the inclusion criteria

Patients with a diagnosis of functional dyspepsia meeting the inclusion criteria

Patients who received a G-POEM procedure meeting the inclusion criteria

Outcomes

Primary Outcome Measures

Frequency and direction of contractions
Physiologic parameter measuring the frequency and direction of stomach contractions
Number and location of luminal transit markers in the antrum, fundus, and overall
Physiologic parameter measuring the number and location of luminal transit markers in the stomach
Largest diameter of the pylorus
Physiologic parameter measuring the diameter of the pylorus
Dyspepsia Severity Scale symptom ratings at baseline and during the study at timepoints with discomfort if present.
Evaluating the dyspepsia Severity Scale symptom ratings (range of score 0-20) at baseline and during the study at timepoints with discomfort if present.
Procedure related adverse events
Procedure related adverse events during or after the study session

Secondary Outcome Measures

Full Information

First Posted
July 24, 2021
Last Updated
October 20, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05004012
Brief Title
Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility
Official Title
AnX/Ankon Navicam Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
May 22, 2023 (Actual)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This is a feasibility study to assess the utility of magnetically controlled capsule endoscopy in the evaluation of gastroparesis and functional dyspepsia
Detailed Description
Gastroparesis and functional dyspepsia can both present with abdominal pain, dyspepsia, nausea, emesis, or early satiety. Gastroparesis is a syndrome defined as delayed gastric emptying. Functional dyspepsia is a symptom-based diagnosis in which the pathophysiology is multifactorial. Delayed gastric emptying is present in 25-35% of patients with functional dyspepsia. The study investigators propose the Navicam magnetically controlled capsule endoscopy (MCCE) system as a potential new method of evaluating gastric motility disorders. The MCCE is FDA approved for visualization of the stomach. The ability to visualize gastric peristalsis in real time, without interference from an endoscope, has never been demonstrated. The MCCE system could allow physicians to evaluate gastric motility with a test that has clear advantages over the current methods: it is fast, non-invasive, and has no radiation exposure, has artificial intelligence (AI) capabilities, while at the same time provides a visual assessment of the gastric anatomy. In this pilot feasibility study, the study investigators plan to enroll 5 male and female adult healthy volunteers, 5 male and female patients with gastroparesis, 5 male and female patients with functional dyspepsia (epigastric pain syndrome and/or postprandial distress syndrome with or without gastric emptying delay), and 2 patients with gastroparesis who have undergone a G-POEM procedure. The study investigators will compare gastric motor patterns in the different sections of the stomach and symptoms during fasting and a sham meal between groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis, Dyspepsia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Four groups of participants will be studied: gastroparesis, functional dyspepsia, gastroparesis patients s/p G-POEM, and healthy controls.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
No diagnosis of gastroparesis, functional dyspepsia, or prior G-POEM
Arm Title
Gastroparesis
Arm Type
Other
Arm Description
Patients with a diagnosis of gastroparesis meeting the inclusion criteria
Arm Title
Functional Dyspepsia
Arm Type
Other
Arm Description
Patients with a diagnosis of functional dyspepsia meeting the inclusion criteria
Arm Title
G-POEM
Arm Type
Other
Arm Description
Patients who received a G-POEM procedure meeting the inclusion criteria
Intervention Type
Device
Intervention Name(s)
Magnetically Controlled Capsule Endoscopy
Intervention Description
This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
Primary Outcome Measure Information:
Title
Frequency and direction of contractions
Description
Physiologic parameter measuring the frequency and direction of stomach contractions
Time Frame
Through study completion, an average of 1 year
Title
Number and location of luminal transit markers in the antrum, fundus, and overall
Description
Physiologic parameter measuring the number and location of luminal transit markers in the stomach
Time Frame
Through study completion, an average of 1 year
Title
Largest diameter of the pylorus
Description
Physiologic parameter measuring the diameter of the pylorus
Time Frame
Through study completion, an average of 1 year
Title
Dyspepsia Severity Scale symptom ratings at baseline and during the study at timepoints with discomfort if present.
Description
Evaluating the dyspepsia Severity Scale symptom ratings (range of score 0-20) at baseline and during the study at timepoints with discomfort if present.
Time Frame
Through study completion, an average of 1 year
Title
Procedure related adverse events
Description
Procedure related adverse events during or after the study session
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Must meet one of the following categories: Gastroparesis Meets diagnostic criteria for gastroparesis: Evidence of delayed gastric emptying documented with a standard 2 hour or 4 hour gastric emptying scintigraphy exam Absence of mechanical obstruction Exhibits cardinal symptoms of early satiety, post-prandial fullness, nausea, vomiting, bloating, and upper abdominal pain Gastrointestinal cardinal symptom index (GCSI) score > 0 (i.e., the presence of at least mild severity of >1 of 3 symptoms of nausea/vomiting, postprandial fullness/early satiety, and/or bloating). Functional Dyspepsia Meets Rome IV diagnostic criteria for functional dyspepsia: Criteria fulfilled for the last 3 months with symptom onset at least six months prior to diagnosis No evidence of organic, systemic, or metabolic disease that is likely to explain the symptoms on routine investigations (including at upper endoscopy) Meet criteria for Epigastric pain syndrome and/or Postprandial distress syndrome Epigastric Pain Syndrome At least 1 of the following symptoms at least 1 day per week Bothersome epigastric pain Bothersome epigastric burning Postprandial Distress Syndrome At least 1 of the following symptoms at least 3 days per week Bothersome postprandial fullness Bothersome early satiation G-POEM The G-POEM procedure must have been performed at least 4 weeks prior to screening. GCSI score is < 3 which correlates to mild or less symptom severity. Controls None of the above conditions Exclusion Criteria: Another active disorder or treatment which could explain or contribute to symptoms in the opinion of the Investigator (including but not limited to gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics). Gastrectomy, fundoplication, vagotomy, bariatric surgery, post-surgical cause of gastroparesis, or gastric stimulation device surgically implanted within the last year. Prior G-POEM procedure for gastroparesis is allowed for the group of post-G-POEM study subjects. Dysphagia, swallowing disorder Suspected bowel obstruction or perforation Gastric or parenteral feeding within 4 weeks of screening Pregnancy or nursing History of an eating disorder within 2 years of screening Recent history (within six months of screening) of Alcohol Use Disorder or Substance Use Disorder as defined in DSM-5. Uncontrolled thyroid disease Unstable cardiac, respiratory, hepatic or renal disease Evidence of uncontrolled blood glucose (including HbA1C >9 or metabolic crisis in past 60 days). Use of prohibited medication or medication with anti-nausea, antiemetic, neuromodulating, or prokinetic effect within 2 weeks of the screening visit EXCEPT when administered on a stable daily dosing schedule (stable for at least 1 month prior to the screening visit). Use of as needed or daily opioids within the past 1 month. Pyloric injection of neurotoxins (e.g. botulinum type A or B) within 3 months of the Screening visit. Altered mental status (e.g., hepatic encephalopathy) that limits the ability to swallow a capsule Expected to have Magnetic Resonance Imaging (MRI) examination within 30 days. No reliable contact information - no phone, no permanent address. Pacemaker or ICD Inability to avoid using the bathroom for urination and/or bowel movements for the duration of the study. Metal Implant (ie metal hip arthroplasty, surgical mesh, coronary or arterial stent) Prior bowel surgery Severe claustrophobia Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Chang, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22591037
Citation
Lacy BE, Talley NJ, Locke GR 3rd, Bouras EP, DiBaise JK, El-Serag HB, Abraham BP, Howden CW, Moayyedi P, Prather C. Review article: current treatment options and management of functional dyspepsia. Aliment Pharmacol Ther. 2012 Jul;36(1):3-15. doi: 10.1111/j.1365-2036.2012.05128.x. Epub 2012 May 16.
Results Reference
background
PubMed Identifier
23147521
Citation
Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13.
Results Reference
background
PubMed Identifier
12848636
Citation
Revicki DA, Rentz AM, Dubois D, Kahrilas P, Stanghellini V, Talley NJ, Tack J. Development and validation of a patient-assessed gastroparesis symptom severity measure: the Gastroparesis Cardinal Symptom Index. Aliment Pharmacol Ther. 2003 Jul 1;18(1):141-50. doi: 10.1046/j.1365-2036.2003.01612.x.
Results Reference
background
PubMed Identifier
15354277
Citation
Revicki DA, Rentz AM, Tack J, Stanghellini V, Talley NJ, Kahrilas P, De La Loge C, Trudeau E, Dubois D. Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders. Clin Gastroenterol Hepatol. 2004 Sep;2(9):769-77. doi: 10.1016/s1542-3565(04)00348-9.
Results Reference
background
PubMed Identifier
31394286
Citation
Carbone F, Vanuytsel T, Tack J. Analysis of Postprandial Symptom Patterns in Subgroups of Patients With Rome III or Rome IV Functional Dyspepsia. Clin Gastroenterol Hepatol. 2020 Apr;18(4):838-846.e3. doi: 10.1016/j.cgh.2019.07.053. Epub 2019 Aug 5.
Results Reference
background

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Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility

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