Intestinal StricturePOISENCT03886324
POISE I Pilot Study
A study testing GIE Medical Drug Coated Balloon in people with Intestinal Stricture, run by GIE Medical at 1 site in Paraguay.
Trial summary
POISE I study is a feasibility study for evaluating the safety and efficacy of DCB. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intestinal Stricture
- What is being tested?
- GIE Medical Drug Coated Balloon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteParaguay
- Study dates
- 25 Feb 2019to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 80 years.
- Subjects for whom the balloon dilation would be chosen in standard practice, and the scope could not pass stricture.
- Recurrent to plain balloon dilation with at least 2 previous balloon dilation or stricturotomy sessions and recurrence of intestine obstructive symptoms/signs.
- Symptoms of intestinal partial occlusion
- Length of stenosis/stricture ≤ 7 cm
- Up to 2 discrete strictures.
- Ability to undergo periodic endoscopic follow-up.
- Voluntary participation and provided written informed consent.
Who cannot join
- Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
- Contraindication to endoscopy, anesthesia or deep sedation.
- Malignant bowel stricture.
- Extrinsic benign bowel stricture due to adhesion.
- Stricture complicated with abscess, fistula, ulceration or associated with mesenteric vessel thrombosis
- More than 2 stenosis/stricture lesions.
Show all 22Show fewer
- Length of stenosis/stricture > 7 cm.
- Stricture not accessible by endoscopy.
- Suspected perforation of the gastrointestinal tract
- Acute bowel obstruction requiring urgent surgical intervention
- Low rectal or anal strictures
- Severe coagulation disorders (platelets < 70000; INR > 1.8).
- Active systemic infection
- Allergy to paclitaxel or any components of the delivery system.
- Life expectancy of less than 12 months.
- Drug abuse or on chronic steroid therapy for comorbidities.
- Unwilling or unable to comply with the follow-up study requirements.
- Lacking capacity to provide informed consent.
- Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
- Currently participation in another pre-market drug or medical device clinical study.
- Chronic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use.
- Currently requiring abdominal radiation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paclitaxel-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Intestinal Stricture
POISE I study is a feasibility study for evaluating the safety and efficacy of DCB.
Read the detailed description
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.
- Conditions
- Intestinal Stricture
- Being tested
- GIE Medical Drug Coated Balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIE Medical Drug Coated BalloonCombination product
Stricture patients treated by DCB
| Study group | Role | What they receive |
|---|---|---|
| DCB Treatment | Experimental | Stricture patients treated by DCB Receives: Combination Product: GIE Medical Drug Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (5)
Procedure success
defined as subjects who were treated with GIE DCB achieved at least one scale improvement of the Endoscopic Obstructive Scale (EOS).
Measured: 6 months
Percent subjects with improvement in Endoscopic Obstructive Scale (EOS)
Analyzed by 1, 2, or 3 scale improvement.
Measured: 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).
Measured: 30 days, 3 months, 6 months, and 12 months
Number of repeated stricture dilation procedures
Repeat dilation for stricture recurrence
Measured: 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.
Measured: Time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start25 Feb 2019
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- GIE Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bo Shen, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886324
- Sponsor's protocol ID
- PR2002
- Acronym
- POISE
- Status last verified
- Aug 2022
- First submitted
- 20 Mar 2019
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shen B, Adorno-Garayo CR. Initial safety and efficacy of a novel drug-coated balloon for treatment of benign intestinal strictures. IGIE. 2024 Jan 5;3(1):10-14. doi: 10.1016/j.igie.2023.12.002. eCollection 2024 Mar.
PubMed 41648897
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Intestinal Stricture
- ClinicalTrials.gov ID
- NCT03886324
- Acronym / sponsor ID
- POISE / PR2002
- Conditions
- Intestinal Stricture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GIE MedicalIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
POISE I study is a feasibility study for evaluating the safety and efficacy of DCB.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCB Treatment | Experimental | Combination Product: GIE Medical Drug Coated BalloonStricture patients treated by DCB |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 and ≤ 80 years.
- Subjects for whom the balloon dilation would be chosen in standard practice, and the scope could not pass stricture.
- Recurrent to plain balloon dilation with at least 2 previous balloon dilation or stricturotomy sessions and recurrence of intestine obstructive symptoms/signs.
- Symptoms of intestinal partial occlusion
- Length of stenosis/stricture ≤ 7 cm
Key exclusion criteria (22 listed)
- Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
- Contraindication to endoscopy, anesthesia or deep sedation.
- Malignant bowel stricture.
- Extrinsic benign bowel stricture due to adhesion.
- Stricture complicated with abscess, fistula, ulceration or associated with mesenteric vessel thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIE Medical Drug Coated BalloonStricture patients treated by DCB | Combination product | DCB Treatment |
Primary outcome
Incident of serious balloon dilation-related complications
Time frame: 30 days
Perforation, bleeding requiring endoscopic or surgical interventions or blood transfusion, severe abdominal pain requiring medications, infection requiring hospitalization or IV antibiotics
5 secondary outcomes
Procedure success
Time frame: 6 months
Percent subjects with improvement in Endoscopic Obstructive Scale (EOS)
Time frame: 6 months
Change in obstructive symptoms using the Obstructive Symptom Score (OSS).
Time frame: 30 days, 3 months, 6 months, and 12 months
Number of repeated stricture dilation procedures
Time frame: 30 days, 3 months, 6 months, and 12 months
Procedural technical success
Time frame: Time of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Derived from this study: PubMed 41648897Shen B, Adorno-Garayo CR. Initial safety and efficacy of a novel drug-coated balloon for treatment of benign intestinal strictures. IGIE. 2024 Jan 5;3(1):10-14. doi: 10.1016/j.igie.2023.12.002. eCollection 2024 Mar.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Shen, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIE Medical Drug Coated Balloon in people with Intestinal Stricture, run by GIE Medical at 1 site in Paraguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident of serious balloon dilation-related complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03886324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.