Clinical trial NCT03458390: Use of a Colon Irrigation Device as a Preparation for a Colon Visualization Procedure
Official title: Colon Irrigation Using HyGIeaCare as Prep for PillCam COLON Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Screening Colonoscopy
Lead sponsor: HyGIeaCare, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2018-03-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: HyGIeaCare colon irrigation procedure and PillCam COLON procedure
Primary purpose: DEVICE_FEASIBILITY

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 polyethylene glycol-electrolyte solution preparation.

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
* Nothing by mouth 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

Eligibility 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 Ejection Fraction \<50%)
   2. GastrointestinaI: Intestinal perforation, carcinoma of the rectum, Fissures or fistula, Severe hemorrhoids, Abdominal hernia, recent colon or rectal surgery, abdominal surgery
   3. Genitourinary: 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

Primary outcomes:
measure: Effectiveness of colon irrigation
timeFrame: 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 outcomes:
measure: Evaluation of adverse events
timeFrame: To be evaluated the day of the procedure
measure: Evaluation of patient satisfaction
timeFrame: To be evaluated on the day of the procedure
Other outcomes:
Locations:
city: Austin
country: United States
facility: HyGIeaCare Center
state: Texas
Study officials:
affiliation: Eastern Virginia Medical Center
name: David A Johnson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Austin Gastroenterology
name: William Stassen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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. doi: 10.1016/j.cgh.2007.04.019. Epub 2007 Jul 10.