Screening ColonoscopyNCT03458390
Use of a Colon Irrigation Device as a Preparation for a Colon Visualization Procedure
A study testing HyGIeaCare colon irrigation in people with Screening Colonoscopy, run by HyGIeaCare, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Screening Colonoscopy
- What is being tested?
- HyGIeaCare colon irrigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2019to 19 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient referred for the PillCam COLON procedure
Who cannot join
- -
- HyGIeaCare:
- 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
- Patient is treated long-term with narcotics.
- Patient does not have any of the contraindications listed below:
- Cardiac: Congestive heart failure (NYHA class III or IV or Ejection Fraction <50%)
Show all 25Show fewer
- GastrointestinaI: Intestinal perforation, carcinoma of the rectum, Fissures or fistula, Severe hemorrhoids, Abdominal hernia, recent colon or rectal surgery, abdominal surgery
- Genitourinary: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites
- Abdominal surgery within the last 6 months
- Pregnancy
- PillCam COLON:
- Subject has dysphagia or any swallowing disorder
- Subject has congestive heart failure
- Subject has Diabetes type I.
- 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
- Subject has a cardiac pacemaker or other implanted electro medical device.
- Subject has any allergy or other known contraindication to the medications used in the study
- Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- 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.
- Subject with gastrointestinal motility disorders
- Subject has known delayed gastric emptying
- Subject has any condition, which precludes compliance with study and/or device instructions.
- 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.
- Subject suffers from life threatening conditions
- Subject currently participating in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colon Irrigation Using HyGIeaCare as Prep for PillCam COLON Procedure
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.
Read the 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
- Conditions
- Screening Colonoscopy
- Being tested
- HyGIeaCare colon irrigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyGIeaCare colon irrigationDevice
Also called PillCam COLON
PillCam COLON for visualization of bowel lining
| Study group | Role | What they receive |
|---|---|---|
| HyGIeaCare and PillCam COLON | Experimental | Patient will receive the HyGIeaCare colon irrigation prior to their PillCam COLON procedure Receives: Device: HyGIeaCare colon irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 (2)
Evaluation of adverse events
The CTCAE tool will be used to evaluate outcomes
Measured: To be evaluated the day of the procedure
Evaluation of patient satisfaction
A standardized questionnaire will be used to measure outcomes
Measured: To be evaluated on the day of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start27 Jun 2019
- Primary completion19 Jan 2020
- Study completion19 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Screening ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- HyGIeaCare colon irrigation procedure and PillCam COLON procedure
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- HyGIeaCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- David A Johnson, MD, Principal investigator, Eastern Virginia Medical CenterWilliam Stassen, MD, Principal investigator, Austin Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458390
- Sponsor's protocol ID
- HGP-0005
- Status last verified
- Jun 2019
- First submitted
- 2 Mar 2018
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Research outcomes will be evaluated by external statistician.
Publications
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 25803399Singh 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.
PubMed 17625982
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colon Irrigation Using HyGIeaCare as Prep for PillCam COLON Procedure
- ClinicalTrials.gov ID
- NCT03458390
- Acronym / sponsor ID
- HGP-0005
- Conditions
- Screening Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- HyGIeaCare, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 19 Jan 2020 (actual)
- Study completion
- 19 Jan 2020 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- HyGIeaCare colon irrigation procedure and PillCam COLON procedure
| Arm | Type | Receives |
|---|---|---|
| HyGIeaCare and PillCam COLON | Experimental | Device: HyGIeaCare colon irrigationPatient will receive the HyGIeaCare colon irrigation prior to their PillCam COLON procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient referred for the PillCam COLON procedure
Key exclusion criteria (25 listed)
- -
- 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
- Patient is treated long-term with narcotics.
- Patient does not have any of the contraindications listed below:
- Subject has dysphagia or any swallowing disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyGIeaCare colon irrigationAlso: PillCam COLONPillCam COLON for visualization of bowel lining | Device | HyGIeaCare and PillCam COLON |
Primary outcome
Effectiveness of colon irrigation
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.
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).
2 secondary outcomes
Evaluation of adverse events
Time frame: To be evaluated the day of the procedure
Evaluation of patient satisfaction
Time frame: To be evaluated on the day of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Background: PubMed 25803399Sommers 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.
- Results publication: PubMed 17625982Singh 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.
- Hydrotherapy compared with polyethylene glycol-electrolyte solution lavage and aqueous sodium phosphate as bowel preparation for elective colonoscopy: A prospective, randomized, single blinded trialLink provided by the sponsor.
- Randomized trial comparing high volume rectal water irrigation with standard 4 liter split-dose polyethlene glycol-electrolyte solution preparation before colonoscopyLink provided by the sponsor.
- HyGIeaCare® Preparation for Colonoscopy-A Technical Update for SuccessLink provided by the sponsor.
- Multi-Dimensional Gastrointestinal Symptom Severity Index: Validation of a Brief GI Symptom Assessment ToolLink provided by the sponsor.
- Individual participant dataSharing planned: No. Research outcomes will be evaluated by external statistician.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Johnson, MD principal investigator
Eastern Virginia Medical Center
William Stassen, MD principal investigator
Austin Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HyGIeaCare colon irrigation in people with Screening Colonoscopy, run by HyGIeaCare, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of colon irrigation (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03458390, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.