Vero Beach, Florida, 32960, United States
NCT Number: NCT00164177
Evaluation Of The Efficacy Of HalfLYTELY For Bowel Cleansing Before Virtual Colonoscopy and Conventional Colonoscopy.
To evaluate the efficacy of standard HalfLYTELY® as a bowel cleansing preparation for adult patients undergoing virtual colonoscopy (VC).
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
HalfLytely
DrugPrimary outcomes
-
Efficacy of the preparation to produce a degree of fecal matter and residual liquid that would not interfere with VC or CC.
Secondary outcomes
-
Incidence of adverse events.
Sponsors and collaborators
Lead sponsor
Braintree Laboratories
Industry
Registry information
Official study title
A Preliminary Evaluation Of The Efficacy Of HalfLYTELY® For Bowel Cleansing Before Virtual Colonoscopy (VC) and Conventional Colonoscopy (CC).
Important dates
- Study start
- 2004
- Primary completion
- 2004
- First posted
- Sep 14, 2005
- Registry last updated
- Feb 7, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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