CompletedNot Applicable

Study of Hemospray for Lower Gastrointestinal Hemorrhage

Canada50 participantsStarted 2015-01

Plain-language summary

This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient in which Hemospray is used to treat an endoscopically confirmed nonvariceal lower GI bleed requiring hemostasis Exclusion Criteria: * Less than 19 years old * Unwilling or unable to sign and date the informed consent * Pregnant, lactating or planning to become pregnant within 30 days of the procedure * Contraindicated to undergo colonoscopy Medical/Endoscopic Exclusion Criteria * Actual or suspected lower GI perforation or fistula * Bleeding originating from inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) * Actual or suspected ischemic colitis or infectious colitis * Unable to visualize site of active bleeding (such as suspected diverticular bleed where source is unable to be identified) * Unable to treat active site of bleeding (e.g., bleeding site cannot be reached by the colonoscope)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of device related adverse events

Timeframe: 30 days

Trial details

NCT IDNCT02099435

SponsorCook Group Incorporated

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-11-06

View on ClinicalTrials.gov More Colonic Diverticula trials

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.