Intestinal Strictures Related to Crohn´s DiseaseNCT04718493
Endoscopic Stenting in Crohn Related Strictures
A study testing Self-expandable metal stent and Balloon dilatation in people with Intestinal Strictures Related to Crohn´s Disease, run by Sahlgrenska University Hospital.
Trial summary
Prospective, randomized-controlled trial comparing self-expandable metal stent versus ballon dialtation only for the endoscopic treatment of benign strictures related to Crohn´s disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intestinal Strictures Related to Crohn´s Disease
- What is being tested?
- Self-expandable metal stent and Balloon dilatation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to May 2020
- 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
- Benign high-grade Crohn stricture
Who cannot join
- Unwillingness to participate
- Planned surgery
- High risk for bleeding
About this study
Prospective, randomized-controlled trial comparing self-expandable metal stent versus ballon dialtation only for the endoscopic treatment of benign strictures related to Crohn´s disease.
- Being tested
- Self-expandable metal stent, Balloon dilatation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-expandable metal stentProcedure or surgery
Endoscopic stenting of intestinal stricture related to Crohn´s disease
Balloon dilatationProcedure or surgery
Endoscopic balloon dilatation of intestinal stricture related to Crohn´s disease
| Study group | Role | What they receive |
|---|---|---|
| Stent | Experimental | Not described Receives: Procedure: Self-expandable metal stent |
| Dilatation | Active comparator | Not described Receives: Procedure: Balloon dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
Measured: Peroperative
Adverse event rate
Measured: Within 7 days
Secondary outcomes (1)
Clinical success rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study startJan 2013
- Primary completionDec 2016
- Study completionMay 2020
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 Strictures Related to Crohn´s DiseaseStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Hedenström, Sahlgrenska University Hospital
- Investigators
- Per-Ove Stotzer, Ass Prof, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718493
- Sponsor's protocol ID
- Project database VGR 95381
- Status last verified
- Jun 2023
- First submitted
- 18 Jan 2021
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hedenstrom P, Stotzer PO. Endoscopic treatment of Crohn-related strictures with a self-expandable stent compared with balloon dilation: a prospective, randomised, controlled study. BMJ Open Gastroenterol. 2021 Mar;8(1):e000612. doi: 10.1136/bmjgast-2021-000612.
PubMed 33722805
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Stenting in Crohn Related Strictures
- ClinicalTrials.gov ID
- NCT04718493
- Acronym / sponsor ID
- Project database VGR 95381
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 22 Jan 2021 (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.
Prospective, randomized-controlled trial comparing self-expandable metal stent versus ballon dialtation only for the endoscopic treatment of benign strictures related to Crohn´s disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent | Experimental | Procedure: Self-expandable metal stent |
| Dilatation | Active comparator | Procedure: Balloon dilatation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Benign high-grade Crohn stricture
Key exclusion criteria (3 listed)
- Unwillingness to participate
- Planned surgery
- High risk for bleeding
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 |
|---|---|---|
| Self-expandable metal stentEndoscopic stenting of intestinal stricture related to Crohn´s disease | Procedure or surgery | Stent |
| Balloon dilatationEndoscopic balloon dilatation of intestinal stricture related to Crohn´s disease | Procedure or surgery | Dilatation |
Primary outcome
Technical success rate
Time frame: Peroperative
Adverse event rate
Time frame: Within 7 days
1 secondary outcome
Clinical success rate
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Derived from this study: PubMed 33722805Hedenstrom P, Stotzer PO. Endoscopic treatment of Crohn-related strictures with a self-expandable stent compared with balloon dilation: a prospective, randomised, controlled study. BMJ Open Gastroenterol. 2021 Mar;8(1):e000612. doi: 10.1136/bmjgast-2021-000612.
- Individual participant dataSharing planned: No
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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.
Per-Ove Stotzer, Ass Prof principal investigator
Sahlgrenska University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Self-expandable metal stent and Balloon dilatation in people with Intestinal Strictures Related to Crohn´s Disease, run by Sahlgrenska University Hospital.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Technical success rate (time frame: Peroperative). The study lists 2 primary outcomes in all. 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 NCT04718493, 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 28 Jun 2023.