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Clinical Trial NCT06051955 (OSS) for Colonoscopy, Bowel Preparation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Evaluation of an Oral Sodium Sulfate Solution for Patients With Prior Difficult or Incomplete Cleansing (OSS) 120

Recruiting
Clinical Trial NCT06051955 (OSS) is an interventional study for Colonoscopy, Bowel Preparation that is recruiting. It started on October 11, 2023 with plans to enroll 120 participants. Led by Lawrence Charles Hookey, it is expected to complete by September 30, 2024. The latest data from ClinicalTrials.gov was last updated on April 3, 2024.
Brief Summary
This case series aims to evaluate the effectiveness and tolerability of Oral Sulfate Solution (OSS) in patients who had previously experienced poor colonoscopy preparation.
Detailed Description
This study aims to evaluate the effectiveness of Oral Sodium Sulfate (OSS) in patients who have had poor colon preparation in the past. The study includes patients who had issues during their previous colonoscopy, such as needing extensive washing, inadequate preparation, a recommendation for shorter surveillance intervals, or adequate preparation for larger polyps but not smaller lesions.

Poor colon cleansing durin...

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Official Title

Evaluation of an Oral Sodium Sulfate Solution for Patients With Prior Difficult or Incomplete Cleansing, a Progressive Case Series.

Conditions
ColonoscopyBowel Preparation
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • OSS
  • 6039506
NCT ID Number
NCT06051955
Start Date (Actual)
2023-10-11
Last Update Posted
2024-04-03
Completion Date (Estimated)
2024-09-30
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Oral sodium sulfate
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Otheroral sodium sulfate
OSS is a colon cleansing agent administered in a split dose fashion, inducing diarrhea by drawing water into the intestine.
Oral sodium sulfate
All participants enrolled in this study will use Oral Sodium Sulfate as their bowel cleansing agent.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Effectiveness
The primary outcome is proportion of patients with an adequate preparation (Boston preparation scale 6 or greater, with no section less than 2).
1-2 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  1. Patients Age 18 to 80 inclusive

  2. Able to read and understand the English language

  3. History of poor bowel prep defined as:

    • Required extensive washing, as noted in the narrative of the endoscopist report.
    • Inadequate preparation
    • Endoscopist recommended shorter interval surveillance due to poor prep
    • adequate for polyps >5mm but not smaller lesions

  1. Patients who have inflammatory bowel disease
  2. Patients with ileus or bowel obstruction
  3. Patients with history of colorectal resection
  4. Patients receiving combined upper and lower endoscopies
  5. Patients with ascites
  6. Patients with previously documented severe renal impairment
  7. Unable to provide consent
  8. Pregnant or lactating female (females of child-bearing potential will undergo urine pregnancy testing)
  9. Patients who have had a recent myocardial infarction(<6months)
Lawrence Charles Hookey logoLawrence Charles Hookey
Pendopharm logoPendopharm
Study Responsible Party
Lawrence Charles Hookey, Sponsor-Investigator, Professor, Queen's University
Study Central Contact
Contact: Jackie McKay, 613-544-3400, [email protected]
Contact: Rana Mohanna, 613-544-3400, [email protected]
2 Study Locations in 1 Countries

Ontario

Hotel Dieu Hospital, Kingston, Ontario, K7L 5G2, Canada
Jackie McKay, Contact, 613 544 3400, [email protected]
Lawrence Hookey, Principal Investigator
Recruiting
Hotel Dieu Hospital, Kingston, Ontario, K7L5G2, Canada
Lawrence Hookey, Contact, [email protected]
Recruiting