Inflammatory Bowel DiseasesNCT06725563
Endoscopically Placed Lumen-Apposing Metal Stents for the Treatment of Symptomatic Intestinal Strictures in Individuals With Inflammatory Bowel Disease
A study testing Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures in people with Inflammatory Bowel Diseases and Stricture; Bowel, run by Ottawa Hospital Research Institute.
Trial summary
This is a single-center prospective pilot study in patients with symptomatic partially obstructing intestinal strictures without severe active inflammation or penetrating complications, evaluating the use of LAMS with respect to symptom and quality of life improvement and the development of stent-related complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Stricture; Bowel
- What is being tested?
- Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Established Diagnosis of inflammatory bowel disease
- Symptomatic, single, fibrostenotic or anastomotic stricture \<6 cm in length without severe active inflammation, pre-stenotic intestinal fistula or penetrating complication, and within reach of the adult colonoscope (colon or terminal ileum)
- Ability to accurately gauge stricture length with imaging and safely deploy the stent using conventional fluoroscopic techniques
- Able to provide informed consent
Who cannot join
- More than one intestinal stricture
- Stricture out of reach of standard adult colonoscope
- High-grade stricture (complete or near complete bowel obstruction
- Severe active inflammation in the stricture or associated penetrating complication, including fistula, inflammatory phlegmon or abscess
- Contraindications for endoscopic therapy, including:
- Complete Bowel obstruction
Show all 9Show fewer
- Severe cardiorespiratory comorbidity
- Unable to tolerate sedation or anesthesia
- Non-reversible coagulopathy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Endoscopically Placed Lumen-Apposing Metal Stents as a Safe Alternative to Surgery for the Treatment of Symptomatic Intestinal Strictures in Individuals With Inflammatory Bowel Disease
This is a single-center prospective pilot study in patients with symptomatic partially obstructing intestinal strictures without severe active inflammation or penetrating complications, evaluating the use of LAMS with respect to symptom and quality of life improvement and the development of stent-related complications.
Read the detailed description
This will be a prospective case series study in ~20 IBD patients with symptomatic partially-obstructing intestinal strictures \&lt; 6 cm in length without severe active inflammation (large or deep ulcers at distal entrance or moderate-severe friability or severe inflammatory changes in the stricture on radiographic imaging, at the discretion of the referring IBD physician or treating therapeutic endoscopist) or penetrating complications (pre-stenotic fistula or intra-abdominal phlegmon or abscess), evaluating the use of LAMS with respect to symptom and quality of life improvement and the development of stent-related complications.
The objective of this project is to evaluate the safety and efficacy of LAMS for the treatment of short segment, symptomatic, IBD-related strictures.
The hope is that positive results from this pilot study will provide sufficient rationale to trigger a larger scale multicenter study to fully assess the efficacy of endoscopic stenting for IBD-related strictures.
- Conditions
- Inflammatory Bowel Diseases, Stricture; Bowel
- Being tested
- Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures
- Medical subject headings
- Inflammatory Bowel Diseases, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopically placed lumen-apposing metal stents for the treatment of IBD-stricturesProcedure or surgery
We will apply standard procedures for endoluminal stenting. A therapeutic colonoscope will be advanced through the bowel up until the stricture. A guidewire will be passed through the lumen at the stricture site. LAMS will be used for strictures \<6cm, with stents ranging in size from 10-16mm in diameter and up to 60mm in length. The stent will be deployed across the stricture with the assistance of endoscopic and fluoroscopic imaging. Individuals will undergo a repeat colonoscopy in 1-3 months to remove the stent.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures | Experimental | Individuals will receive endoscopic lumen-apposing metal stents. The specific size of the stent used will depend on the length of the stricture. All LAMS placements are part of one arm. Receives: Procedure: Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
defined as persistent improvement of obstructive symptoms and establishment of adequate oral caloric intake at 12 months following stent removal, measured using quality of life pre- and post-endoscopic stenting measured using short inflammatory bowel disease questionnaire (SIBDQ), pre- and post-stenting nutritional/health outcomes measured using Saskatchewan IBD-Nutrition Risk (SaskIBD-NR Tool)
Measured: 12-months following stent removal
Secondary outcomes (3)
Technical success
defined as successful deployment of the stent without stent-related complications, including stent migration or perforation by the time of stent removal
Measured: 1-3 months
Patient satisfaction
Endoscopic stenting patient satisfaction measured using a decision regret form
Measured: 12 months
Incidence of adverse events
Incidence of post procedure adverse events (stent migration, abdominal pain, perforation, infection, bleeding)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will receive lumen-apposing metal stents (LAMS) as a treatment for IBD-related strictures. The size of the stent used will depend on the length of the stricture. All LAMS placements are part of a single arm.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Avijit Chatterjee, MD, MSc., Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725563
- Sponsor's protocol ID
- CRRF ID: 5849
- Status last verified
- Dec 2024
- First submitted
- 28 May 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Coward S, Benchimol EI, Kuenzig ME, Windsor JW, Bernstein CN, Bitton A, Jones JL, Lee K, Murthy SK, Targownik LE, Pena-Sanchez JN, Rohatinsky N, Ghandeharian S, Im JHB, Davis T, Weinstein J, Goddard Q, Bennett J, Caplan L, Bergevin M, Yang XY, Mason K, Sanderson R, Brass C, Kaplan GG. The 2023 Impact of Inflammatory Bowel Disease in Canada: Epidemiology of IBD. J Can Assoc Gastroenterol. 2023 Sep 5;6(Suppl 2):S9-S15. doi: 10.1093/jcag/gwad004. eCollection 2023 Sep.
PubMed 37674492Mitropoulou MA, Fradelos EC, Lee KY, Malli F, Tsaras K, Christodoulou NG, Papathanasiou IV. Quality of Life in Patients With Inflammatory Bowel Disease: Importance of Psychological Symptoms. Cureus. 2022 Aug 28;14(8):e28502. doi: 10.7759/cureus.28502. eCollection 2022 Aug.
PubMed 36185946Nasr S, Dahmani W, Jaziri H, Hammami A, Slama AB, Ameur WB, Elleuch N, Ksiaa M, Jmaa A. Exploring work productivity loss in patients with inflammatory bowel disease. Future Sci OA. 2023 Jun 7;9(8):FSO872. doi: 10.2144/fsoa-2022-0034. eCollection 2023 Sep.
PubMed 37621842Shen B. Principles, Preparation, Indications, Precaution, and Damage Control of Endoscopic Therapy in Inflammatory Bowel Disease. Gastrointest Endosc Clin N Am. 2022 Oct;32(4):597-614. doi: 10.1016/j.giec.2022.05.005. Epub 2022 Sep 7.
PubMed 36202505Kuenzig ME, Benchimol EI, Lee L, Targownik LE, Singh H, Kaplan GG, Bernstein CN, Bitton A, Nguyen GC, Lee K, Cooke-Lauder J, Murthy SK. The Impact of Inflammatory Bowel Disease in Canada 2018: Direct Costs and Health Services Utilization. J Can Assoc Gastroenterol. 2019 Feb;2(Suppl 1):S17-S33. doi: 10.1093/jcag/gwy055. Epub 2018 Nov 2.
PubMed 31294382Lin V, Gogenur S, Pachler F, Fransgaard T, Gogenur I. Risk Prediction for Complications in Inflammatory Bowel Disease Surgery: External Validation of the American College of Surgeons' National Surgical Quality Improvement Program Surgical Risk Calculator. J Crohns Colitis. 2023 Jan 27;17(1):73-82. doi: 10.1093/ecco-jcc/jjac114.
PubMed 35973971Wiebe K, Kelley S, Kirsch RE. Revisiting the concept of urgency in surgical prioritization and addressing backlogs in elective surgery provision. CMAJ. 2022 Aug 2;194(29):E1037-E1039. doi: 10.1503/cmaj.220420. No abstract available.
PubMed 35918085Springer JE, Doumouras AG, Saleh F, Lee J, Amin N, Cadeddu M, Eskicioglu C, Hong D. Drivers of Inpatient Costs After Colorectal Surgery Within a Publicly Funded Healthcare System. Dis Colon Rectum. 2019 Jun;62(6):747-754. doi: 10.1097/DCR.0000000000001309.
PubMed 31094961Jeong SJ, Park J. Endoscopic Management of Benign Colonic Obstruction and Pseudo-Obstruction. Clin Endosc. 2020 Jan;53(1):18-28. doi: 10.5946/ce.2019.058. Epub 2019 Oct 24.
PubMed 31645090Jena A, Chandnani S, Jain S, Sharma V, Rathi P. Efficacy of endoscopic over-the-scope clip fixation for preventing migration of self-expandable metal stents: a systematic review and meta-analysis. Surg Endosc. 2023 May;37(5):3410-3418. doi: 10.1007/s00464-023-09893-z. Epub 2023 Jan 30.
PubMed 36717426Sharma P, McCarty TR, Chhoda A, Costantino A, Loeser C, Muniraj T, Ryou M, Thompson CC. Alternative uses of lumen apposing metal stents. World J Gastroenterol. 2020 Jun 7;26(21):2715-2728. doi: 10.3748/wjg.v26.i21.2715.
PubMed 32550749Nunez F P, Krugliak Cleveland N, Quera R, Rubin DT. Evolving role of endoscopy in inflammatory bowel disease: Going beyond diagnosis. World J Gastroenterol. 2021 May 28;27(20):2521-2530. doi: 10.3748/wjg.v27.i20.2521.
PubMed 34092973Chandan S, Dhindsa BS, Khan SR, Deliwala S, Kassab LL, Mohan BP, Chandan OC, Loras C, Shen B, Kochhar GS. Endoscopic Stenting in Crohn's Disease-related Strictures: A Systematic Review and Meta-analysis of Outcomes. Inflamm Bowel Dis. 2023 Jul 5;29(7):1145-1152. doi: 10.1093/ibd/izac153.
PubMed 35880681Medas R, Ferreira-Silva J, Girotra M, Barakat M, Tabibian JH, Rodrigues-Pinto E. Best Practices in Esophageal, Gastroduodenal, and Colonic Stenting. GE Port J Gastroenterol. 2022 Nov 7;30(Suppl 1):19-34. doi: 10.1159/000527202. eCollection 2023 Sep.
PubMed 37818397Das R, Singh R, Din S, Lund J, Krishnamoorthy R, Hearing S, Norton B, Williams J, Fraser C, Goddard A, Cole A. Therapeutic resolution of focal, predominantly anastomotic Crohn's disease strictures using removable stents: outcomes from a single-center case series in the United Kingdom. Gastrointest Endosc. 2020 Aug;92(2):344-352. doi: 10.1016/j.gie.2020.01.053. Epub 2020 Feb 18.
PubMed 32081614
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopically Placed Lumen-Apposing Metal Stents as a Safe Alternative to Surgery for the Treatment of Symptomatic Intestinal Strictures in Individuals With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06725563
- Acronym / sponsor ID
- CRRF ID: 5849
- Conditions
- Inflammatory Bowel Diseases, Stricture; Bowel
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Dec 2024 (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.
This is a single-center prospective pilot study in patients with symptomatic partially obstructing intestinal strictures without severe active inflammation or penetrating complications, evaluating the use of LAMS with respect to symptom and quality of life improvement and the development of stent-related complications.
Detailed description
This will be a prospective case series study in ~20 IBD patients with symptomatic partially-obstructing intestinal strictures \&lt; 6 cm in length without severe active inflammation (large or deep ulcers at distal entrance or moderate-severe friability or severe inflammatory changes in the stricture on radiographic imaging, at the discretion of the referring IBD physician or treating therapeutic endoscopist) or penetrating complications (pre-stenotic fistula or intra-abdominal phlegmon or abscess), evaluating the use of LAMS with respect to symptom and quality of life improvement and the development of stent-related complications.
The objective of this project is to evaluate the safety and efficacy of LAMS for the treatment of short segment, symptomatic, IBD-related strictures.
The hope is that positive results from this pilot study will provide sufficient rationale to trigger a larger scale multicenter study to fully assess the efficacy of endoscopic stenting for IBD-related strictures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will receive lumen-apposing metal stents (LAMS) as a treatment for IBD-related strictures. The size of the stent used will depend on the length of the stricture. All LAMS placements are part of a single arm.
| Arm | Type | Receives |
|---|---|---|
| Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures | Experimental | Procedure: Endoscopically placed lumen-apposing metal stents for the treatment of IBD-stricturesIndividuals will receive endoscopic lumen-apposing metal stents. The specific size of the stent used will depend on the length of the stricture. All LAMS placements are part of one arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age
- Established Diagnosis of inflammatory bowel disease
- Symptomatic, single, fibrostenotic or anastomotic stricture \<6 cm in length without severe active inflammation, pre-stenotic intestinal fistula or penetrating complication, and within reach of the adult colonoscope (colon or terminal ileum)
- Ability to accurately gauge stricture length with imaging and safely deploy the stent using conventional fluoroscopic techniques
- Able to provide informed consent
Key exclusion criteria (9 listed)
- More than one intestinal stricture
- Stricture out of reach of standard adult colonoscope
- High-grade stricture (complete or near complete bowel obstruction
- Severe active inflammation in the stricture or associated penetrating complication, including fistula, inflammatory phlegmon or abscess
- Contraindications for endoscopic therapy, including:
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 |
|---|---|---|
| Endoscopically placed lumen-apposing metal stents for the treatment of IBD-stricturesWe will apply standard procedures for endoluminal stenting. A therapeutic colonoscope will be advanced through the bowel up until the stricture. A guidewire will be passed through the lumen at the stricture site. LAMS will be used for strictures \<6cm, with stents ranging in size from 10-16mm in diameter and up to 60mm in length. The stent will be deployed across the stricture with the assistance of endoscopic and fluoroscopic imaging. Individuals will undergo a repeat colonoscopy in 1-3 months to remove the stent. | Procedure or surgery | Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures |
Primary outcome
Clinical success
Time frame: 12-months following stent removal
defined as persistent improvement of obstructive symptoms and establishment of adequate oral caloric intake at 12 months following stent removal, measured using quality of life pre- and post-endoscopic stenting measured using short inflammatory bowel disease questionnaire (SIBDQ), pre- and post-stenting nutritional/health outcomes measured using Saskatchewan IBD-Nutrition Risk (SaskIBD-NR Tool)
3 secondary outcomes
Technical success
Time frame: 1-3 months
Patient satisfaction
Time frame: 12 months
Incidence of adverse events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 37674492Coward S, Benchimol EI, Kuenzig ME, Windsor JW, Bernstein CN, Bitton A, Jones JL, Lee K, Murthy SK, Targownik LE, Pena-Sanchez JN, Rohatinsky N, Ghandeharian S, Im JHB, Davis T, Weinstein J, Goddard Q, Bennett J, Caplan L, Bergevin M, Yang XY, Mason K, Sanderson R, Brass C, Kaplan GG. The 2023 Impact of Inflammatory Bowel Disease in Canada: Epidemiology of IBD. J Can Assoc Gastroenterol. 2023 Sep 5;6(Suppl 2):S9-S15. doi: 10.1093/jcag/gwad004. eCollection 2023 Sep.
- Background: PubMed 36185946Mitropoulou MA, Fradelos EC, Lee KY, Malli F, Tsaras K, Christodoulou NG, Papathanasiou IV. Quality of Life in Patients With Inflammatory Bowel Disease: Importance of Psychological Symptoms. Cureus. 2022 Aug 28;14(8):e28502. doi: 10.7759/cureus.28502. eCollection 2022 Aug.
- Background: PubMed 37621842Nasr S, Dahmani W, Jaziri H, Hammami A, Slama AB, Ameur WB, Elleuch N, Ksiaa M, Jmaa A. Exploring work productivity loss in patients with inflammatory bowel disease. Future Sci OA. 2023 Jun 7;9(8):FSO872. doi: 10.2144/fsoa-2022-0034. eCollection 2023 Sep.
- Background: PubMed 36202505Shen B. Principles, Preparation, Indications, Precaution, and Damage Control of Endoscopic Therapy in Inflammatory Bowel Disease. Gastrointest Endosc Clin N Am. 2022 Oct;32(4):597-614. doi: 10.1016/j.giec.2022.05.005. Epub 2022 Sep 7.
- Background: PubMed 31294382Kuenzig ME, Benchimol EI, Lee L, Targownik LE, Singh H, Kaplan GG, Bernstein CN, Bitton A, Nguyen GC, Lee K, Cooke-Lauder J, Murthy SK. The Impact of Inflammatory Bowel Disease in Canada 2018: Direct Costs and Health Services Utilization. J Can Assoc Gastroenterol. 2019 Feb;2(Suppl 1):S17-S33. doi: 10.1093/jcag/gwy055. Epub 2018 Nov 2.
- Background: PubMed 35973971Lin V, Gogenur S, Pachler F, Fransgaard T, Gogenur I. Risk Prediction for Complications in Inflammatory Bowel Disease Surgery: External Validation of the American College of Surgeons' National Surgical Quality Improvement Program Surgical Risk Calculator. J Crohns Colitis. 2023 Jan 27;17(1):73-82. doi: 10.1093/ecco-jcc/jjac114.
- Background: PubMed 35918085Wiebe K, Kelley S, Kirsch RE. Revisiting the concept of urgency in surgical prioritization and addressing backlogs in elective surgery provision. CMAJ. 2022 Aug 2;194(29):E1037-E1039. doi: 10.1503/cmaj.220420. No abstract available.
- Background: PubMed 31094961Springer JE, Doumouras AG, Saleh F, Lee J, Amin N, Cadeddu M, Eskicioglu C, Hong D. Drivers of Inpatient Costs After Colorectal Surgery Within a Publicly Funded Healthcare System. Dis Colon Rectum. 2019 Jun;62(6):747-754. doi: 10.1097/DCR.0000000000001309.
- Background: PubMed 31645090Jeong SJ, Park J. Endoscopic Management of Benign Colonic Obstruction and Pseudo-Obstruction. Clin Endosc. 2020 Jan;53(1):18-28. doi: 10.5946/ce.2019.058. Epub 2019 Oct 24.
- Background: PubMed 36717426Jena A, Chandnani S, Jain S, Sharma V, Rathi P. Efficacy of endoscopic over-the-scope clip fixation for preventing migration of self-expandable metal stents: a systematic review and meta-analysis. Surg Endosc. 2023 May;37(5):3410-3418. doi: 10.1007/s00464-023-09893-z. Epub 2023 Jan 30.
- Background: PubMed 32550749Sharma P, McCarty TR, Chhoda A, Costantino A, Loeser C, Muniraj T, Ryou M, Thompson CC. Alternative uses of lumen apposing metal stents. World J Gastroenterol. 2020 Jun 7;26(21):2715-2728. doi: 10.3748/wjg.v26.i21.2715.
- Background: PubMed 34092973Nunez F P, Krugliak Cleveland N, Quera R, Rubin DT. Evolving role of endoscopy in inflammatory bowel disease: Going beyond diagnosis. World J Gastroenterol. 2021 May 28;27(20):2521-2530. doi: 10.3748/wjg.v27.i20.2521.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
Avijit Chatterjee, MD, MSc. principal investigator
Ottawa Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures in people with Inflammatory Bowel Diseases and Stricture; Bowel, run by Ottawa Hospital Research Institute.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 10 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avijit Chatterjee, MD, MSc. (6137378899 ext. 79917, achatterjee@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: 12-months following stent removal). 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 NCT06725563, which also lists 16 linked publications.
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 10 Dec 2024.