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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 February 2013 |
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Main ID: |
NCT00164177 |
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Date of registration:
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09/09/2005 |
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Primary sponsor: |
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Public title:
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Evaluation Of The Efficacy Of HalfLYTELY For Bowel Cleansing Before Virtual Colonoscopy and Conventional Colonoscopy.
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Scientific title:
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A Preliminary Evaluation Of The Efficacy Of HalfLYTELY® For Bowel Cleansing Before Virtual Colonoscopy (VC) and Conventional Colonoscopy (CC). |
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Date of first enrolment:
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October 2004 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00164177 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
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Countries of recruitment
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United States
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Contacts
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Name:
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H. Paul Hatten, Jr., MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Indian River Radiology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female outpatients who are undergoing colonoscopy for routinely accepted
indications, Evaluation of BE results, GI bleeding, Anemia of unknown etiology,
Neoplastic disease surveillance, Endosonography, Inflammatory bowel disease (except
as noted below), Unknown diarrhea etiology, Prior Polypectomy, Laser therapy, Foreign
body removal and decompression (except as noted below).
- 18 years of age or older.
- Otherwise in good health, as determined by physical exam and medical history.
- If female, and of child-bearing potential, is using an acceptable form of birth
control (hormonal birth control, IUD, double-barrier method, or vasectomized spouse)
- Subject has read and signed the written informed consent document prior to study
participation
Exclusion Criteria:
- Subjects with known or suspected bowel perforation or obstruction, inflammatory bowel
disease, ileus, acute alimentary tract surgery, significant gastroparesis or gastric
outlet obstruction, appendicitis, gastric retention, toxic colitis, toxic megacolon
or rectal bleeding.
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- Subjects with uncontrolled cardiovascular disease
- Subjects who, in the opinion of the investigator, should not be included in the study
for any reason, including inability to follow study procedures.
- Subjects who have participated in an investigational clinical surgical, drug or
device study within the past 30 days.
- Subjects who are pregnant or lactating.
- Subjects who are allergic to Polyethyleneglycol.
- Subjects receiving non-study laxatives, antacids and prokinetic agents during the
study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colonoscopy
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Intervention(s)
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Drug: HalfLytely
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Primary Outcome(s)
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Efficacy of the preparation to produce a degree of fecal matter and residual liquid that would not interfere with VC or CC.
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Secondary Outcome(s)
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Incidence of adverse events.
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Secondary ID(s)
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F38-VC-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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