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Evaluation Of The Efficacy Of HalfLYTELY For Bowel Cleansing Before Virtual Colonoscopy and Conventional Colonoscopy.
This study has been completed.
Study NCT00164177   Information provided by Braintree Laboratories
First Received: September 9, 2005   No Changes Posted

September 9, 2005
September 9, 2005
October 2004
 
Efficacy of the preparation to produce a degree of fecal matter and residual liquid that would not interfere with VC or CC.
Same as current
No Changes Posted
Incidence of adverse events.
Same as current
 
Evaluation Of The Efficacy Of HalfLYTELY For Bowel Cleansing Before Virtual Colonoscopy and Conventional Colonoscopy.
A Preliminary Evaluation Of The Efficacy Of HalfLYTELY® For Bowel Cleansing Before Virtual Colonoscopy (VC) and Conventional Colonoscopy (CC).

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

 
Phase IV
Interventional
Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Colonoscopy
Drug: HalfLytely
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
20
 
 

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.
Both
18 Years and older
 
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00164177
 
F38-VC-002
Braintree Laboratories
 
Principal Investigator: H. Paul Hatten, Jr., MD Indian River Radiology
Braintree Laboratories
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP