Full Text View
Tabular View
No Study Results Posted
Related Studies
Evaluation Of The Efficacy Of HalfLYTELY For Bowel Cleansing Before Virtual Colonoscopy and Conventional Colonoscopy.
This study has been completed.

First Received on September 9, 2005.   No Changes Posted
Sponsor: Braintree Laboratories
Information provided by: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT00164177
  Purpose

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


Condition Intervention Phase
Colonoscopy
Drug: HalfLytely
Phase IV

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Preliminary Evaluation Of The Efficacy Of HalfLYTELY® For Bowel Cleansing Before Virtual Colonoscopy (VC) and Conventional Colonoscopy (CC).

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • 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:
  • Incidence of adverse events.

Estimated Enrollment: 20
Study Start Date: October 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00164177

Locations
United States, Florida
Vero Beach, Florida, United States, 32960
Sponsors and Collaborators
Braintree Laboratories
Investigators
Principal Investigator: H. Paul Hatten, Jr., MD Indian River Radiology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00164177     History of Changes
Other Study ID Numbers: F38-VC-002
Study First Received: September 9, 2005
Last Updated: September 9, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:
virtual colonoscopy
colonoscopy preparation
bowel prep

ClinicalTrials.gov processed this record on February 12, 2012