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History of Changes for Study: NCT03458390
Colon Irrigation Using HyGIeaCare as Prep for PillCam COLON Procedure
Latest version (submitted July 29, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 2, 2018 None (earliest Version on record)
2 March 8, 2018 References, Eligibility, Study Description, Study Status and Study Identification
3 June 27, 2019 Recruitment Status, Study Status, IPDSharing, Contacts/Locations and Oversight
4 July 29, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT03458390
Submitted Date:  March 2, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: HGP-0005
Brief Title: Colon Irrigation Using HyGIeaCare as Prep for PillCam COLON Procedure
Official Title: Colon Irrigation Using HyGIeaCare as Prep for PillCam COLON Procedure
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2018
Overall Status: Not yet recruiting
Study Start: April 1, 2018
Primary Completion: September 29, 2018 [Anticipated]
Study Completion: December 31, 2018 [Anticipated]
First Submitted: March 2, 2018
First Submitted that
Met QC Criteria:
March 2, 2018
First Posted: March 8, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
March 2, 2018
Last Update Posted: March 8, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: HyGIeaCare, Inc.
Responsible Party: Sponsor
Collaborators: Medtronic
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: A prospective, single center, study to evaluate the effectiveness of the HyGIeaCare Prep when used in combination with the PillCam COLON; the hypothesis is that the HyGIeaCare Prep will be easier for the patients to tolerate, and the results will be as good as the existing oral preparation.
Detailed Description:

Patients who agree to participate in the study will have their HyGIeaCare procedure and then will present to the PillCam COLON room, in the same suite for the PillCam COLON procedure.

The commercial preparations for the PillCam COLON procedure will be the same, except the HyGIeaCare procedure will replace the Split-PEG prep.

2-days prior:

  • Normal diet
  • 10 glasses of liquid

    1-day prior:

  • Clear liquid diet all day
  • Dulcolax 2 tabs at 2pm and 2 tabs at 8pm
  • NPO after midnight

Day of Procedure:

  • 6am- Dulcolax 2 tabs
  • 8am- HyGIeaCare Procedure
  • 9am- ingest PillCam Colon
  • 10am- ingest Reglan
  • At small bowel detection, drink 10oz SUPREP and 32oz water
  • 3hrs later- drink 10oz SUPREP and 32oz water
  • 2hrs later- insert suppository
  • 2hrs later- light meal
Open or close this module Conditions
Conditions: Screening Colonoscopy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Device Feasibility
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
HyGIeaCare colon irrigation procedure and PillCam COLON procedure
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 10 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: HyGIeaCare and PillCam COLON
Patient will receive the HyGIeaCare colon irrigation prior to their PillCam COLON procedure
Device: HyGIeaCare colon irrigation
PillCam COLON for visualization of bowel lining
Other Names:
  • PillCam COLON
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Effectiveness of colon irrigation
Effectiveness of the HyGIeaCare Prep will be measured using a 5-point scale to evaluate the visual quality of bowel cleanliness identified in the PillCam Colon video (Excellent, Good, Fair, Adequate, Poor).

[Time Frame: Immediately after colon irrigation, PillCam COLON will be administered. A video will be taken of the procedure which will be used to measure the effectiveness of the colon irrigation.]
Secondary Outcome Measures:
2. Evaluation of adverse events
The CTCAE tool will be used to evaluate outcomes

[Time Frame: To be evaluated the day of the procedure]
3. Evaluation of patient satisfaction
A standardized questionnaire will be used to measure outcomes

[Time Frame: To be evaluated on the day of the procedure]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Patient referred for the PillCam COLON procedure

Exclusion Criteria:

-

HyGIeaCare:

  1. Patient has any condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study
  2. Patient is treated long-term with narcotics.
  3. Patient does not have any of the contraindications listed below:
    1. Cardiac: Congestive heart failure (NYHA class III or IV or EF <50%)
    2. GI: Intestinal perforation, carcinoma of the rectum, Fissures or fistula, Severe hemorrhoids, Abdominal hernia, recent colon or rectal surgery, abdominal surgery
    3. GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites
    4. Abdominal surgery within the last 6 months
    5. Pregnancy

PillCam COLON:

  1. Subject has dysphagia or any swallowing disorder
  2. Subject has congestive heart failure
  3. Subject has Diabetes type I.
  4. Subject has had prior abdominal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
  5. Subject has a cardiac pacemaker or other implanted electro medical device.
  6. Subject has any allergy or other known contraindication to the medications used in the study
  7. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
  8. Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.
  9. Subject with gastrointestinal motility disorders
  10. Subject has known delayed gastric emptying
  11. Subject has any condition, which precludes compliance with study and/or device instructions.
  12. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
  13. Subject suffers from life threatening conditions
  14. Subject currently participating in another clinical study
Open or close this module Contacts/Locations
Central Contact Person: Dawn B Burleson, RN,MBA
Telephone: 678-896-1575
Email: dawn.burleson@hygieacare.com
Central Contact Backup: Darlene Gorny, RN
Telephone: 512-368-8357
Email: darlene.gorny@hygieacare.com
Study Officials: David A Johnson, MD
Principal Investigator
Eastern Virginia Medical Center
William Stassen, MD
Principal Investigator
Austin Gastroenterology
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Research outcomes will be evaluated by external statistician.
Open or close this module References
Citations: Sommers T, Corban C, Sengupta N, Jones M, Cheng V, Bollom A, Nurko S, Kelley J, Lembo A. Emergency department burden of constipation in the United States from 2006 to 2011. Am J Gastroenterol. 2015 Apr;110(4):572-9. doi: 10.1038/ajg.2015.64. Epub 2015 Mar 24. PubMed 25803399
[Study Results] Singh G, Lingala V, Wang H, Vadhavkar S, Kahler KH, Mithal A, Triadafilopoulos G. Use of health care resources and cost of care for adults with constipation. Clin Gastroenterol Hepatol. 2007 Sep;5(9):1053-8. Epub 2007 Jul 10. PubMed 17625982
Links: Description: Hydrotherapy Compared with PEG-ES Lavage and Aqueous Sodium Phosphate as Bowel Preparation for Elective Colonoscopy: A Prospectve, Randomized, Single Blinded Trial
Description: RANDOMIZED TRIAL COMPARING HIGH VOLUME RECTAL WATER IRRIGATION WITH STANDARD 4 L SPLIT-DOSE PEG PREPARATION BEFORE COLONOSCOPY
Description: Multi-Dimensional Gastrointestinal Symptom Severity Index: Validation of a Brief GI Symptom Assessment Tool
Available IPD/Information:

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