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Evaluation Of The Efficacy Of HalfLYTELY For Bowel Cleansing Before Virtual Colonoscopy and Conventional Colonoscopy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00164177
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 7, 2013
Sponsor:
Information provided by:
Braintree Laboratories

Brief Summary:
To evaluate the efficacy of standard HalfLYTELY® as a bowel cleansing preparation for adult patients undergoing virtual colonoscopy (VC).

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: HalfLytely Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Preliminary Evaluation Of The Efficacy Of HalfLYTELY® For Bowel Cleansing Before Virtual Colonoscopy (VC) and Conventional Colonoscopy (CC).
Study Start Date : October 2004
Actual Primary Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy




Primary Outcome Measures :
  1. Efficacy of the preparation to produce a degree of fecal matter and residual liquid that would not interfere with VC or CC.

Secondary Outcome Measures :
  1. Incidence of adverse events.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164177


Locations
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United States, Florida
Vero Beach, Florida, United States, 32960
Sponsors and Collaborators
Braintree Laboratories
Investigators
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Principal Investigator: H. Paul Hatten, Jr., MD Indian River Radiology
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ClinicalTrials.gov Identifier: NCT00164177    
Other Study ID Numbers: F38-VC-002
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013
Keywords provided by Braintree Laboratories:
virtual colonoscopy
colonoscopy preparation
bowel prep