An interventional study of GIE Medical Drug Coated Balloon in Intestinal Stricture, sponsored by GIE Medical. Active, not recruiting at 1 site in Paraguay. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-17.
Sponsored by GIE Medical · Not applicable, Interventional, and Treatment
POISE I study is a feasibility study for evaluating the safety and efficacy of DCB.
The study is designed to determine the safety and effectiveness for drug coated balloon (DCB) for treating intestinal strictures.
Up to 15 subjects are planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.
456 studies on the registry are indexed under Constriction, Pathologic; 109 are open to participants now.
This study's enrollment of 10 is below the median of 72 across 295 interventional studies indexed under Constriction, Pathologic.
Browse Constriction, Pathologic studies →GIE Medical is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stricture patients treated by DCB
Combination Product: GIE Medical Drug Coated Balloon
Stricture patients treated by DCB
Incident of serious balloon dilation-related complications
Perforation, bleeding requiring endoscopic or surgical interventions or blood transfusion, severe abdominal pain requiring medications, infection requiring hospitalization or IV antibiotics
Time frame: 30 days
Procedure success
defined as subjects who were treated with GIE DCB achieved at least one scale improvement of the Endoscopic Obstructive Scale (EOS).
Time frame: 6 months
Percent subjects with improvement in Endoscopic Obstructive Scale (EOS)
Analyzed by 1, 2, or 3 scale improvement.
Time frame: 6 months
Change in obstructive symptoms using the Obstructive Symptom Score (OSS).
The Obstructive Symptom Score (OSS) is a composite measure of the total number of days of obstructive abdominal pain and the severity over a fourteen-day period using a 5-point Likert scale. (1=no pain, 2=mild, 3=moderate, 4=severe, 5=unbearable).
Time frame: 30 days, 3 months, 6 months, and 12 months
Number of repeated stricture dilation procedures
Repeat dilation for stricture recurrence
Time frame: 30 days, 3 months, 6 months, and 12 months
Procedural technical success
Successful endoscopic passage followed by successful delivery of the drug-coated balloon to the stricture area without resistance, inflated balloon to the defined diameter, DCB withdraw after deflating balloon without device malfunction.
Time frame: Time of procedure
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2019 (actual). Primary completion is estimated for Dec 2025, 82 months after the start.
Of 43 industry-sponsored interventional studies with no phase under Constriction, Pathologic, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 58. This study's planned 82 months is above that.
Counting every sponsor, half of 133 studies reached it within 36 months; a quarter within 18 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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