Crohn DiseaseLong-ProtDilatNCT06036680
Long-term Study of Endoscopic Treatment of Stenosis in Crohn´s Disease
An observational study of Crohn Disease and Stenosis, run by Hospital Mutua de Terrassa at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease, Stenosis
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 19 Dec 2022to 31 Dec 2023
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: CD patients included in the ProtDilat study that finished the follow-up
Who may be able to join
- Age18-75.
- CD with predominating de novo and/or anastomotic fibrotic stenosis confirmed by endoscopy and radiology and accessible by endoscopy (colonoscopy).
- Stenosis previously treated with a stent and/or dilatation and with at least one year asymptomatic.
- Intestinal occlusion or sub-occlusion symptomatology.
- Refractoriness to conventional medical treatment (no response to accelerated step-up of normal therapeutic scale).
- Stenosis length < 10 cm.
- Maximum 2 stenoses.
- Informed consent of patient.
Who cannot join
- No informed consent of patient.
- Stenosis complicated by abscess, fistula, or important activity associated with CD not limited to the stenosis area.
- Stenosis previously treated with a stent and/or dilatation and with less than one year asymptomatic.
- Pregnancy or lactation.
- Any clinical condition that prevents the performance of endoscopy.
- Stenosis inaccessible by colonoscopy.
Show all 10Show fewer
- No obstructive symptoms.
- Stenosis length ≥ 10 cm.
- Presenting more than 2 stenoses.
- Serious coagulation disorder (platelets < 70000; INR > 1.5)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Follow-up ProtDilat Study; Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease: Self-expandable Metal Stent vs. Endoscopic Balloon Dilatation
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. Several endoscopic techniques, as an alternative to surgery, have been used in the treatment of fibrostenotic CD, with similar efficacy and lower risk of complications.
The ProtDilat study (NCT02395354) showed that both endoscopic balloon dilation (EBD) and self-expandable metal stents (SEMS) are efficient and safe for the treatment of stenosis in CD, while EBD shows therapeutic superiority (80.5 vs 51.3 %) at one year follow-up. However, this difference was not observed in the subanalysis of patients with stenosis > 3 cm (EBD: 66.7% vs SEMS: 63.6%) but with a lower cost for EBD (EDB 1,365.63 euros versus SEMS 1,923.55 euros).
Read more
Therefore, SEMS could be a suitable treatment option for longer stenoses in which EBD has proven to be less efficacious. Moreover, the long-term efficacy of both endoscopic treatments is still debated with scare information and without data from a clinical trial.
The aim of this study is to assess the long-term efficacy of EBD and SEMS, through the follow-up of the patients included in the ProtDilat study, being the primary objective of the study the percentage of patients free of surgical intervention at the end of follow-up. Retrospective study based on data from the ProtDilat trial (patients with CD, obstructive symptoms, with stenosis < 10cm). Data on medical, endoscopic and surgical treatment and smoking habits are collected.
- Conditions
- Crohn Disease, Stenosis
- Keywords
- endoscopic balloon dilatation, self-expanding metal stent
- Medical subject headings
- Crohn Disease, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic balloon dilatation (EBD) treated CD patients | Not described | |
| Self-expandable metal stent (SEMS) treated CD patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of surgery-free patients post-treatment
Measured: end of long-term follow up (median 7 years post-treatment)
Secondary outcomes (3)
Percentage of patients that have not required any endoscopic retreatment
Measured: end of long-term follow up (median 7 years post-treatment)
Long-term effectiveness of endoscopic treatment (SEMS vs EBD): percentage of patients free of surgery and who have not required any endoscopic retreatment
Measured: end of long-term follow up (median 7 years post-treatment)
Percentage of patients with safety issues and/or complications related to endoscopic or surgical treatment
Measured: end of long-term follow up (median 7 years post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start19 Dec 2022
- Primary completion15 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- Clínica Girona, Complejo Hospitalario Universitario de Vigo, Consorcio Hospital Universitario Clinico de Valencia, Hospital Clinic of Barcelona, Hospital Comarcal de Inca, Hospital de Terrassa, Hospital General la Mancha-Centro, Parc Taulí Hospital Universitari, Hospital Universitario Ramon y Cajal, Hospital General Universitario Reina Sofía de Murcia, Hospital Universitari de Bellvitge, University Hospital of Girona Dr. Josep Trueta, Hospital Universitario La Fe, Hospital Universitari Arnau de Vilanova, Hospital Universitario de Burgos, Hospital Universitario de Cáceres, Hospital Universitario La Paz, Hospital Universitario Rio Hortega
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036680
- Sponsor's protocol ID
- Long-ProtDilat 1
- Acronym
- Long-ProtDilat
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cosnes J, Gower-Rousseau C, Seksik P, Cortot A. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology. 2011 May;140(6):1785-94. doi: 10.1053/j.gastro.2011.01.055.
PubMed 21530745Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Sandborn WJ. The natural history of adult Crohn's disease in population-based cohorts. Am J Gastroenterol. 2010 Feb;105(2):289-97. doi: 10.1038/ajg.2009.579. Epub 2009 Oct 27.
PubMed 19861953Solberg IC, Vatn MH, Hoie O, Stray N, Sauar J, Jahnsen J, Moum B, Lygren I; IBSEN Study Group. Clinical course in Crohn's disease: results of a Norwegian population-based ten-year follow-up study. Clin Gastroenterol Hepatol. 2007 Dec;5(12):1430-8. doi: 10.1016/j.cgh.2007.09.002.
PubMed 18054751Shen B, Kochhar G, Navaneethan U, Liu X, Farraye FA, Gonzalez-Lama Y, Bruining D, Pardi DS, Lukas M, Bortlik M, Wu K, Sood A, Schwartz DA, Sandborn WJ; Global Interventional Inflammatory Bowel Disease Group. Role of interventional inflammatory bowel disease in the era of biologic therapy: a position statement from the Global Interventional IBD Group. Gastrointest Endosc. 2019 Feb;89(2):215-237. doi: 10.1016/j.gie.2018.09.045. Epub 2018 Oct 24.
PubMed 30365985Loras C, Manosa M, Andujar X, Sanchiz V, Marti-Gallostra M, Zabana Y, Gutierrez A, Barreiro-de Acosta M; en representacion de GETECCU. Position Statement. Recommendations of the Spanish Group on Crohn's Disease and Ulcerative Colitis (GETECCU) on the treatment of strictures in Crohn's disease. Gastroenterol Hepatol. 2022 Apr;45(4):315-334. doi: 10.1016/j.gastrohep.2021.07.001. Epub 2021 Jul 15. English, Spanish.
PubMed 34274357Bettenworth D, Gustavsson A, Atreja A, Lopez R, Tysk C, van Assche G, Rieder F. A Pooled Analysis of Efficacy, Safety, and Long-term Outcome of Endoscopic Balloon Dilation Therapy for Patients with Stricturing Crohn's Disease. Inflamm Bowel Dis. 2017 Jan;23(1):133-142. doi: 10.1097/MIB.0000000000000988.
PubMed 28002130Hassan C, Zullo A, De Francesco V, Ierardi E, Giustini M, Pitidis A, Taggi F, Winn S, Morini S. Systematic review: Endoscopic dilatation in Crohn's disease. Aliment Pharmacol Ther. 2007 Dec;26(11-12):1457-64. doi: 10.1111/j.1365-2036.2007.03532.x. Epub 2007 Sep 28.
PubMed 17903236Morar PS, Faiz O, Warusavitarne J, Brown S, Cohen R, Hind D, Abercrombie J, Ragunath K, Sanders DS, Arnott I, Wilson G, Bloom S, Arebi N; Crohn's Stricture Study (CroSS) Group. Systematic review with meta-analysis: endoscopic balloon dilatation for Crohn's disease strictures. Aliment Pharmacol Ther. 2015 Nov;42(10):1137-48. doi: 10.1111/apt.13388. Epub 2015 Sep 11.
PubMed 26358739Navaneethan U, Lourdusamy V, Njei B, Shen B. Endoscopic balloon dilation in the management of strictures in Crohn's disease: a systematic review and meta-analysis of non-randomized trials. Surg Endosc. 2016 Dec;30(12):5434-5443. doi: 10.1007/s00464-016-4902-1. Epub 2016 Apr 28.
PubMed 27126619Thienpont C, D'Hoore A, Vermeire S, Demedts I, Bisschops R, Coremans G, Rutgeerts P, Van Assche G. Long-term outcome of endoscopic dilatation in patients with Crohn's disease is not affected by disease activity or medical therapy. Gut. 2010 Mar;59(3):320-4. doi: 10.1136/gut.2009.180182. Epub 2009 Oct 19.
PubMed 19840991Gustavsson A, Magnuson A, Blomberg B, Andersson M, Halfvarson J, Tysk C. Endoscopic dilation is an efficacious and safe treatment of intestinal strictures in Crohn's disease. Aliment Pharmacol Ther. 2012 Jul;36(2):151-8. doi: 10.1111/j.1365-2036.2012.05146.x. Epub 2012 May 22.
PubMed 22612326Atreja A, Aggarwal A, Dwivedi S, Rieder F, Lopez R, Lashner BA, Brzezinski A, Vargo JJ, Shen B. Safety and efficacy of endoscopic dilation for primary and anastomotic Crohn's disease strictures. J Crohns Colitis. 2014 May;8(5):392-400. doi: 10.1016/j.crohns.2013.10.001. Epub 2013 Nov 1.
PubMed 24189349Andujar X, Loras C, Gonzalez B, Socarras M, Sanchiz V, Bosca M, Domenech E, Calafat M, Rodriguez E, Sicilia B, Calvet X, Barrio J, Guardiola J, Iglesias E, Casanova MJ, Ber Y, Monfort D, Lopez-Sanroman A, Rodriguez-Lago I, Bujanda L, Marquez L, Martin-Arranz MD, Zabana Y, Fernandez-Banares F, Esteve M; ENEIDA registry of GETECCU. Efficacy and safety of endoscopic balloon dilation in inflammatory bowel disease: results of the large multicenter study of the ENEIDA registry. Surg Endosc. 2020 Mar;34(3):1112-1122. doi: 10.1007/s00464-019-06858-z. Epub 2019 May 29.
PubMed 31144122Attar A, Maunoury V, Vahedi K, Vernier-Massouille G, Vida S, Bulois P, Colombel JF, Bouhnik Y; GETAID. Safety and efficacy of extractible self-expandable metal stents in the treatment of Crohn's disease intestinal strictures: a prospective pilot study. Inflamm Bowel Dis. 2012 Oct;18(10):1849-54. doi: 10.1002/ibd.22844. Epub 2011 Dec 11.
PubMed 22161935Levine RA, Wasvary H, Kadro O. Endoprosthetic management of refractory ileocolonic anastomotic strictures after resection for Crohn's disease: report of nine-year follow-up and review of the literature. Inflamm Bowel Dis. 2012 Mar;18(3):506-12. doi: 10.1002/ibd.21739. Epub 2011 May 3.
PubMed 21542067
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up ProtDilat Study; Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease: Self-expandable Metal Stent vs. Endoscopic Balloon Dilatation
- ClinicalTrials.gov ID
- NCT06036680
- Acronym / sponsor ID
- Long-ProtDilat / Long-ProtDilat 1
- Conditions
- Crohn Disease, Stenosis
- Keywords
- endoscopic balloon dilatation, self-expanding metal stent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Collaborators
- Clínica Girona, Complejo Hospitalario Universitario de Vigo, Consorcio Hospital Universitario Clinico de Valencia, Hospital Clinic of Barcelona, Hospital Comarcal de Inca, Hospital de Terrassa, Hospital General la Mancha-Centro, Parc Taulí Hospital Universitari, Hospital Universitario Ramon y Cajal, Hospital General Universitario Reina Sofía de Murcia, Hospital Universitari de Bellvitge, University Hospital of Girona Dr. Josep Trueta, Hospital Universitario La Fe, Hospital Universitari Arnau de Vilanova, Hospital Universitario de Burgos, Hospital Universitario de Cáceres, Hospital Universitario La Paz, Hospital Universitario Rio Hortega
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Sep 2023 (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.
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. Several endoscopic techniques, as an alternative to surgery, have been used in the treatment of fibrostenotic CD, with similar efficacy and lower risk of complications.
The ProtDilat study (NCT02395354) showed that both endoscopic balloon dilation (EBD) and self-expandable metal stents (SEMS) are efficient and safe for the treatment of stenosis in CD, while EBD shows therapeutic superiority (80.5 vs 51.3 %) at one year follow-up. However, this difference was not observed in the subanalysis of patients with stenosis > 3 cm (EBD: 66.7% vs SEMS: 63.6%) but with a lower cost for EBD (EDB 1,365.63 euros versus SEMS 1,923.55 euros).
Therefore, SEMS could be a suitable treatment option for longer stenoses in which EBD has proven to be less efficacious. Moreover, the long-term efficacy of both endoscopic treatments is still debated with scare information and without data from a clinical trial.
The aim of this study is to assess the long-term efficacy of EBD and SEMS, through the follow-up of the patients included in the ProtDilat study, being the primary objective of the study the percentage of patients free of surgical intervention at the end of follow-up. Retrospective study based on data from the ProtDilat trial (patients with CD, obstructive symptoms, with stenosis < 10cm). Data on medical, endoscopic and surgical treatment and smoking habits are collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic balloon dilatation (EBD) treated CD patients | – | – |
| Self-expandable metal stent (SEMS) treated CD patients | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- CD patients included in the ProtDilat study that finished the follow-up
Key inclusion criteria (8 listed)
- Age18-75.
- CD with predominating de novo and/or anastomotic fibrotic stenosis confirmed by endoscopy and radiology and accessible by endoscopy (colonoscopy).
- Stenosis previously treated with a stent and/or dilatation and with at least one year asymptomatic.
- Intestinal occlusion or sub-occlusion symptomatology.
- Refractoriness to conventional medical treatment (no response to accelerated step-up of normal therapeutic scale).
Key exclusion criteria (10 listed)
- No informed consent of patient.
- Stenosis complicated by abscess, fistula, or important activity associated with CD not limited to the stenosis area.
- Stenosis previously treated with a stent and/or dilatation and with less than one year asymptomatic.
- Pregnancy or lactation.
- Any clinical condition that prevents the performance of endoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of surgery-free patients post-treatment
Time frame: end of long-term follow up (median 7 years post-treatment)
3 secondary outcomes
Percentage of patients that have not required any endoscopic retreatment
Time frame: end of long-term follow up (median 7 years post-treatment)
Long-term effectiveness of endoscopic treatment (SEMS vs EBD): percentage of patients free of surgery and who have not required any endoscopic retreatment
Time frame: end of long-term follow up (median 7 years post-treatment)
Percentage of patients with safety issues and/or complications related to endoscopic or surgical treatment
Time frame: end of long-term follow up (median 7 years post-treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Background: PubMed 21530745Cosnes J, Gower-Rousseau C, Seksik P, Cortot A. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology. 2011 May;140(6):1785-94. doi: 10.1053/j.gastro.2011.01.055.
- Background: PubMed 19861953Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Sandborn WJ. The natural history of adult Crohn's disease in population-based cohorts. Am J Gastroenterol. 2010 Feb;105(2):289-97. doi: 10.1038/ajg.2009.579. Epub 2009 Oct 27.
- Background: PubMed 18054751Solberg IC, Vatn MH, Hoie O, Stray N, Sauar J, Jahnsen J, Moum B, Lygren I; IBSEN Study Group. Clinical course in Crohn's disease: results of a Norwegian population-based ten-year follow-up study. Clin Gastroenterol Hepatol. 2007 Dec;5(12):1430-8. doi: 10.1016/j.cgh.2007.09.002.
- Background: PubMed 30365985Shen B, Kochhar G, Navaneethan U, Liu X, Farraye FA, Gonzalez-Lama Y, Bruining D, Pardi DS, Lukas M, Bortlik M, Wu K, Sood A, Schwartz DA, Sandborn WJ; Global Interventional Inflammatory Bowel Disease Group. Role of interventional inflammatory bowel disease in the era of biologic therapy: a position statement from the Global Interventional IBD Group. Gastrointest Endosc. 2019 Feb;89(2):215-237. doi: 10.1016/j.gie.2018.09.045. Epub 2018 Oct 24.
- Background: PubMed 34274357Loras C, Manosa M, Andujar X, Sanchiz V, Marti-Gallostra M, Zabana Y, Gutierrez A, Barreiro-de Acosta M; en representacion de GETECCU. Position Statement. Recommendations of the Spanish Group on Crohn's Disease and Ulcerative Colitis (GETECCU) on the treatment of strictures in Crohn's disease. Gastroenterol Hepatol. 2022 Apr;45(4):315-334. doi: 10.1016/j.gastrohep.2021.07.001. Epub 2021 Jul 15. English, Spanish.
- Background: PubMed 28002130Bettenworth D, Gustavsson A, Atreja A, Lopez R, Tysk C, van Assche G, Rieder F. A Pooled Analysis of Efficacy, Safety, and Long-term Outcome of Endoscopic Balloon Dilation Therapy for Patients with Stricturing Crohn's Disease. Inflamm Bowel Dis. 2017 Jan;23(1):133-142. doi: 10.1097/MIB.0000000000000988.
- Background: PubMed 17903236Hassan C, Zullo A, De Francesco V, Ierardi E, Giustini M, Pitidis A, Taggi F, Winn S, Morini S. Systematic review: Endoscopic dilatation in Crohn's disease. Aliment Pharmacol Ther. 2007 Dec;26(11-12):1457-64. doi: 10.1111/j.1365-2036.2007.03532.x. Epub 2007 Sep 28.
- Background: PubMed 26358739Morar PS, Faiz O, Warusavitarne J, Brown S, Cohen R, Hind D, Abercrombie J, Ragunath K, Sanders DS, Arnott I, Wilson G, Bloom S, Arebi N; Crohn's Stricture Study (CroSS) Group. Systematic review with meta-analysis: endoscopic balloon dilatation for Crohn's disease strictures. Aliment Pharmacol Ther. 2015 Nov;42(10):1137-48. doi: 10.1111/apt.13388. Epub 2015 Sep 11.
- Background: PubMed 27126619Navaneethan U, Lourdusamy V, Njei B, Shen B. Endoscopic balloon dilation in the management of strictures in Crohn's disease: a systematic review and meta-analysis of non-randomized trials. Surg Endosc. 2016 Dec;30(12):5434-5443. doi: 10.1007/s00464-016-4902-1. Epub 2016 Apr 28.
- Background: PubMed 19840991Thienpont C, D'Hoore A, Vermeire S, Demedts I, Bisschops R, Coremans G, Rutgeerts P, Van Assche G. Long-term outcome of endoscopic dilatation in patients with Crohn's disease is not affected by disease activity or medical therapy. Gut. 2010 Mar;59(3):320-4. doi: 10.1136/gut.2009.180182. Epub 2009 Oct 19.
- Background: PubMed 22612326Gustavsson A, Magnuson A, Blomberg B, Andersson M, Halfvarson J, Tysk C. Endoscopic dilation is an efficacious and safe treatment of intestinal strictures in Crohn's disease. Aliment Pharmacol Ther. 2012 Jul;36(2):151-8. doi: 10.1111/j.1365-2036.2012.05146.x. Epub 2012 May 22.
- Background: PubMed 24189349Atreja A, Aggarwal A, Dwivedi S, Rieder F, Lopez R, Lashner BA, Brzezinski A, Vargo JJ, Shen B. Safety and efficacy of endoscopic dilation for primary and anastomotic Crohn's disease strictures. J Crohns Colitis. 2014 May;8(5):392-400. doi: 10.1016/j.crohns.2013.10.001. Epub 2013 Nov 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Stenosis, run by Hospital Mutua de Terrassa at 1 site in Spain.
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 10 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 14 Sep 2023. 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 Spain. 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?
Percentage of surgery-free patients post-treatment (time frame: end of long-term follow up (median 7 years post-treatment)). 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 NCT06036680, which also lists 23 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 14 Sep 2023.