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Device
Doppler Probe Monitoring for Bleeding after Polyp Removal
N/A
Recruiting
Led By Dennis M. Jensen, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Being evaluated for abdominal pain or change in bowel habits or have a large polyp needing removal by EMR or ESD
Surveillance colonoscopy for colon cancer or polyps
Timeline
Screening 3 weeks
Treatment Varies
Follow Up outcome measure will be assessed at 30 days after participants are enrolled.
Awards & highlights
Study Summary
This trial will compare two methods of preventing bleeding after a certain type of surgery. One method uses medical guidelines alone while the other uses a special device to detect bleeding and then treats it.
Who is the study for?
This trial is for ambulatory patients aged 35 or older undergoing colonoscopy due to various reasons, including screening for cancer or polyps, abdominal pain, or bowel habit changes. Participants must be on anticoagulants like Warfarin or antiplatelet drugs such as aspirin and have a post-polypectomy induced ulcer (PPIU) of specific sizes. Those with bleeding disorders, inflammatory bowel diseases, unwillingness to consent or follow up are excluded.Check my eligibility
What is being tested?
The study tests if using a Doppler Endoscopic Probe (DEP) to detect arterial blood flow and treat PPIUs can reduce delayed hemorrhage compared to standard medical guidelines alone. It's a randomized controlled trial focusing on high-risk patients who've had benign colon polyps removed and are at risk of post-procedure bleeding.See study design
What are the potential side effects?
While the document does not specify side effects related to the use of the Doppler Endoscopic Probe (DEP), potential risks may include discomfort during probe use, minor bleeding from the procedure site, or rare complications associated with endoscopic procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am being checked for stomach pain, changes in how often I go to the bathroom, or need a big polyp removed.
Select...
I am under surveillance for colon cancer or polyps.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ outcome measure will be assessed up to 30 days after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcome measure will be assessed up to 30 days after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of participants with delayed Post-Polypectomy Induced Ulcer (PPIU) bleeds.
Secondary outcome measures
The proportion of participants hospitalized.
The proportion of participants with rectal bleeding reported to us but not severe enough to be hospitalized
The total number of hospitalized days.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard endoscopy (not experimental)Experimental Treatment1 Intervention
For Standard treatment group, the Doppler probe will not be used, nor will hemoclip closure of post-polypectomy ulcers be attempted. Standard published guidelines will be followed for management of blood thinners (anti-coagulants) and/or aspirin like drugs (anti-platelet drugs) before and after the colonoscopic polypectomies. This is the standard of care at the investigators' medical centers and part of written instructions that are given to the participants and their referring physicians during the scheduling process and prior to their preparation for screening or surveillance outpatient colonoscopies.
Group II: Doppler treatment (experimental)Experimental Treatment1 Intervention
A colon length catheter (probe) will be used to check the non-bleeding post-polypectomy ulcer with shallow and medium depth Doppler probe settings (< 4 mm deep) for arterial blood flow. If arterial flow is found, treatment through the colonoscope (either hemoclipping or multipolar electrocoagulation probe) will be used to stop the arterial flow. This will be confirmed by rechecking with Doppler probe after endoscopic treatment. Tatoos (Spot method) will be placed on two sides of the ulcer so treated.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,049 Total Patients Enrolled
Kaiser Permanente Bellflower Medical OfficesUNKNOWN
1 Previous Clinical Trials
235 Total Patients Enrolled
University of California, Los AngelesOTHER
1,530 Previous Clinical Trials
10,264,473 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have ongoing rectal bleeding due to a long-term condition like hemorrhoids.I am 35 or older and can walk on my own, going for a planned health check.I have a bleeding disorder that causes me to bleed a lot after surgery or certain medical procedures.I have a condition causing unexplained colon inflammation and frequent rectal bleeding.My blood doesn't clot properly due to a liver, blood, or infection issue, not because of medication.My polyp cannot be fully removed by standard procedures and may be cancerous.I am being checked for stomach pain, changes in how often I go to the bathroom, or need a big polyp removed.I am advised to take blood thinners or anti-platelet drugs due to my PPIU measurement.My colonoscopy showed benign polyps, and I have a polyp 10 mm or larger if on blood thinners, or 15 mm if not.I am under surveillance for colon cancer or polyps.I had a colonoscopy within the last 3 years or was referred for polyp removal.I have inflammatory bowel disease.I have an infection in my colon.
Research Study Groups:
This trial has the following groups:- Group 1: Doppler treatment (experimental)
- Group 2: Standard endoscopy (not experimental)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment open for this clinical experiment at the present time?
"Affirmative. According to clinicaltrials.gov, the trial is currently seeking candidates with its initial posting taking place on February 1st 2017 and latest edit occurring on May 3rd 2022. At present, a total of 170 volunteers are sought from 6 locations across the country."
Answered by AI
How many healthcare facilities are currently conducting this research project?
"This trial is currently enrolling at 6 different sites, located in Los Angeles and its surrounding cities. To minimize any necessary travel, it is recommended that applicants select the closest clinic when applying for this study."
Answered by AI
What is the cap on patient enrollment for this clinical experiment?
"Affirmative, clinicaltrials.gov reports that this research endeavour is actively enrolling participants; the inaugural posting was on February 1st 2017 and was last edited on May 3rd 2022. 170 guinea pigs are needed to be sourced from 6 distinct sites for the trial's completion."
Answered by AI
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