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New treatment option for Crohn Disease
Official title Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.
ClinicalTrials.gov ID: NCT04330846
What this study is testing
- What it's testing
- Stenosis is one of the most frequent complications in patients with Crohn's disease (CD), causing greater morbidity and increasing the probability of repeated surgery and short bowel syndrome (1-3). Endoscopic balloon dilation (EBD) is clearly the treatment of choice for short stenoses located at the anastomosis of previous surgeries (4-6).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 18-80 years of age.
- Crohn's disease with predominantly de novo fibrotic stenosis\ confirmed by endoscopic and radiological tests, accessible by endoscopy (colonoscopy).
- Patients with known stenosis previously treated with stenting and/or dilation performed over one year before the date of inclusion.
- Symptomatology of intestinal occlusion-subocclusion.
- Refractoriness to conventional medical treatment (non-response to the usual accelerated step-up therapeutic approach).
You likely can't join if
- No informed consent from the patient.
- Complicated stenosis with abscess, fistula or significant activity associated with CD not limited to the area of the stenosis.
- Patients with known stenosis previously treated with stenting and/or dilation performed \< 1 year before the date of inclusion.
- Pregnancy or lactation.
- Any clinical situation that prevents the performance of endoscopy or surgery.
- Stenosis not accessible by endoscopy.
See the full eligibility criteria
- 18-80 years of age.
- Crohn's disease with predominantly de novo fibrotic stenosis\ confirmed by endoscopic and radiological tests, accessible by endoscopy (colonoscopy).
- Patients with known stenosis previously treated with stenting and/or dilation performed over one year before the date of inclusion.
- Symptomatology of intestinal occlusion-subocclusion.
- Refractoriness to conventional medical treatment (non-response to the usual accelerated step-up therapeutic approach).
- Stenosis length \< 10 cm.
- Maximum of 2 stenoses.
- Informed consent from patient.
- No informed consent from the patient.
- Complicated stenosis with abscess, fistula or significant activity associated with CD not limited to the area of the stenosis.
- Patients with known stenosis previously treated with stenting and/or dilation performed \< 1 year before the date of inclusion.
- Pregnancy or lactation.
- Any clinical situation that prevents the performance of endoscopy or surgery.
- Stenosis not accessible by endoscopy.
- Asymptomatic patient.
- Stenosis length ≥ 10 cm.
- Presents with \> 2 stenoses.
- Severe coagulation disorders (platelets \ 1.8).
The study team makes the final eligibility decision.
Where it's taking place
- Badalona, Barcelona, Spain
- L'Hospitalet de Llobregat, Barcelona, Spain
- Manresa, Barcelona, Spain
- Sabadell, Barcelona, Spain
- Sant Joan Despí, Barcelona, Spain
- Terrassa, Barcelona, Spain
- Cáceres, Spain
- Girona, Spain
- Inca, Spain
- Lleida, Spain
- Madrid, Spain
- Terrassa, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Badalona, Barcelona, Spain; L'Hospitalet de Llobregat, Barcelona, Spain; Manresa, Barcelona, Spain; Sabadell, Barcelona, Spain; Sant Joan Despí, Barcelona, Spain; Terrassa, Barcelona, Spain and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.