Esophageal DilationNCT03738566
Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management
A study testing Esophageal self-dilation therapy and Endoscopic therapy with esophageal dilation in people with Esophageal Dilation and Refractory Benign Esophageal Stricture, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to see which treatment is more effective in improving the difficulty of swallowing. Researchers are comparing self-dilation to endoscopic dilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Dilation, Refractory Benign Esophageal Stricture
- What is being tested?
- Esophageal self-dilation therapy and Endoscopic therapy with esophageal dilation
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2018to 15 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Refractory benign esophageal stricture defined as an esophageal stricture with persistent dysphagia despite undergoing 5 endoscopic dilations within a 1 year period. Persistent dysphagia will be considered if patients has solid food dysphagia at least once a week
Who cannot join
- Patient with malignant esophageal stricture
- Angulated stricture which prevents safe passage of Maloney dilator in office setting
- In ability to achieve an esophageal diameter of 10 mm with endoscopic dilation
- Known significant esophageal motor disorder (i.e. achalasia, aperistalsis, functional obstruction, jackhammer, distal esophageal spasm)*
- The presence of esophageal stent
- Inability to learn self-dilation secondary to blindness or cognitive dysfunction
- Use of chronic anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management: Randomized Controlled Trial
This study is being done to see which treatment is more effective in improving the difficulty of swallowing. Researchers are comparing self-dilation to endoscopic dilation.
Read the detailed description
Benign esophageal strictures can be challenging condition to treat. The mainstay of treatment is endoscopic dilations. However, 30 to 40% of these strictures recur despite rigorous dilations. Although a consensus definition does not exist, a stricture is typically termed as a refractory benign esophageal stricture (RBES), when there is a failure to maintain luminal patency after at least 5 endoscopic dilations.
Patients with RBES are extremely difficult to manage and the current armamentarium includes repeated endoscopic dilations, corticosteroid or mitomycin C injections, incisional therapy, and/ or temporary stent placement. These procedures are costly, their efficacy can be short-lived, and are associated with great burden both for the patient and clinician.
Esophageal self -dilation therapy (ESDT) is where the patient learns to pass a polyvinyl dilator orally on a routine basis. In past, smaller studies, ESDT appears to be effective for RBES, reducing the number of endoscopic dilations from an average of 21.7 to an average of 1.
- Being tested
- Esophageal self-dilation therapy, Endoscopic therapy with esophageal dilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal self-dilation therapyDevice
Also called ESDT
Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilationProcedure or surgery
A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
| Study group | Role | What they receive |
|---|---|---|
| Standard Clinical Care Endoscopic Dilation Group | Active comparator | Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week. Receives: Procedure: Endoscopic therapy with esophageal dilation |
| Esophageal Self-Dilation Therapy (ESDT) Group | Active comparator | Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months. Receives: Device: Esophageal self-dilation therapy |
| Observational Study Group | Other | Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider. Receives: Device: Esophageal self-dilation therapy; Procedure: Endoscopic therapy with esophageal dilation |
| Standard Clinical Care Endoscopic Dilation, Then ESDT | Experimental | Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy. Receives: Device: Esophageal self-dilation therapy; Procedure: Endoscopic therapy with esophageal dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Endoscopic Interventions
Number of endoscopies required in a 6 month interval in subjects who achieved at least a 10-12 mm esophageal diameter during serial dilation for refractory benign esophageal stricture (RBES) and were subsequently treated with ESDT versus standard clinical care
Measured: 6 months following serial dilation
Secondary outcomes (4)
Length of Days Intervention Free
Number of days from start of study participation to 1st endoscopic intervention for recurrent dysphagia
Measured: 6 months
Mayo Dysphagia Questionnaire (MDQ-30) at Baseline
The MDQ-30 provides a series of questions for patients regarding their swallowing difficulties over the past 30 days. Participants were asked to rate the severity of their troubles swallowing on a scale of 0 to 10; 0 being "Not at all severe" and 10 being "Very severe"
Measured: Baseline
Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months
The MDQ-30 provides a series of questions for patients regarding their swallowing difficulties over the past 30 days. Participants were asked to rate the severity of their troubles swallowing on a scale of 0 to 10; 0 being "Not at all severe" and 10 being "Very severe"
Measured: 12 months
Clinically Significant Adverse Events
Number of clinically significant adverse events including perforation, bleeding and pain
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 posted13 Nov 2018
- Study start21 Nov 2018
- Primary completion2 Jul 2021
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Esophageal DilationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Crossover
- Model description
- Subjects who agreed to participate in the randomized trial were randomized to standard clinical care consisting of endoscopic dilation as needed versus esophageal self-dilation therapy in a 1:1 ratio using a block randomization approach. Subjects randomized to the standard clinical care group were offered cross-over to the esophageal self-dilation therapy if they failed stand of care. Subjects who agreed to take part in in the observational prospective study either commenced ESDT or continued standard clinical care based on shared decision making with their esophageal provider.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey A Alexander, Mayo Clinic
- Investigators
- Jeffrey Alexander, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738566
- Sponsor's protocol ID
- 18-000246
- Status last verified
- May 2023
- First submitted
- 6 Nov 2018
- Last updated
- 24 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Spechler SJ. American gastroenterological association medical position statement on treatment of patients with dysphagia caused by benign disorders of the distal esophagus. Gastroenterology. 1999 Jul;117(1):229-33. doi: 10.1016/s0016-5085(99)70572-x.
PubMed 10381932Mendelson AH, Small AJ, Agarwalla A, Scott FI, Kochman ML. Esophageal anastomotic strictures: outcomes of endoscopic dilation, risk of recurrence and refractory stenosis, and effect of foreign body removal. Clin Gastroenterol Hepatol. 2015 Feb;13(2):263-271.e1. doi: 10.1016/j.cgh.2014.07.010. Epub 2014 Jul 11.
PubMed 25019695de Wijkerslooth LR, Vleggaar FP, Siersema PD. Endoscopic management of difficult or recurrent esophageal strictures. Am J Gastroenterol. 2011 Dec;106(12):2080-91; quiz 2092. doi: 10.1038/ajg.2011.348. Epub 2011 Oct 18.
PubMed 22008891Kochman ML, McClave SA, Boyce HW. The refractory and the recurrent esophageal stricture: a definition. Gastrointest Endosc. 2005 Sep;62(3):474-5. doi: 10.1016/j.gie.2005.04.050. No abstract available.
PubMed 16111985Hordijk ML, Siersema PD, Tilanus HW, Kuipers EJ. Electrocautery therapy for refractory anastomotic strictures of the esophagus. Gastrointest Endosc. 2006 Jan;63(1):157-63. doi: 10.1016/j.gie.2005.06.016.
PubMed 16377340Ramage JI Jr, Rumalla A, Baron TH, Pochron NL, Zinsmeister AR, Murray JA, Norton ID, Diehl N, Romero Y. A prospective, randomized, double-blind, placebo-controlled trial of endoscopic steroid injection therapy for recalcitrant esophageal peptic strictures. Am J Gastroenterol. 2005 Nov;100(11):2419-25. doi: 10.1111/j.1572-0241.2005.00331.x.
PubMed 16279894Eloubeidi MA, Lopes TL. Novel removable internally fully covered self-expanding metal esophageal stent: feasibility, technique of removal, and tissue response in humans. Am J Gastroenterol. 2009 Jun;104(6):1374-81. doi: 10.1038/ajg.2009.133. Epub 2009 Apr 28.
PubMed 19491851Repici A, Hassan C, Sharma P, Conio M, Siersema P. Systematic review: the role of self-expanding plastic stents for benign oesophageal strictures. Aliment Pharmacol Ther. 2010 Jun;31(12):1268-75. doi: 10.1111/j.1365-2036.2010.04301.x. Epub 2010 Mar 17.
PubMed 20236257Repici A, Vleggaar FP, Hassan C, van Boeckel PG, Romeo F, Pagano N, Malesci A, Siersema PD. Efficacy and safety of biodegradable stents for refractory benign esophageal strictures: the BEST (Biodegradable Esophageal Stent) study. Gastrointest Endosc. 2010 Nov;72(5):927-34. doi: 10.1016/j.gie.2010.07.031.
PubMed 21034894Nijhawan S, Udawat HP, Nagar P. Aggressive bougie dilatation and intralesional steroids is effective in refractory benign esophageal strictures secondary to corrosive ingestion. Dis Esophagus. 2016 Nov;29(8):1027-1031. doi: 10.1111/dote.12438. Epub 2015 Nov 6.
PubMed 26542391Repici A, Small AJ, Mendelson A, Jovani M, Correale L, Hassan C, Ridola L, Anderloni A, Ferrara EC, Kochman ML. Natural history and management of refractory benign esophageal strictures. Gastrointest Endosc. 2016 Aug;84(2):222-8. doi: 10.1016/j.gie.2016.01.053. Epub 2016 Jan 30.
PubMed 26828759Dzeletovic I, Fleischer DE, Crowell MD, Pannala R, Harris LA, Ramirez FC, Burdick GE, Rentz LA, Spratley RV Jr, Helling SD, Alexander JA. Self-dilation as a treatment for resistant, benign esophageal strictures. Dig Dis Sci. 2013 Nov;58(11):3218-23. doi: 10.1007/s10620-013-2822-7. Epub 2013 Aug 8.
PubMed 23925823Zehetner J, DeMeester SR, Ayazi S, Demeester TR. Home self-dilatation for esophageal strictures. Dis Esophagus. 2014 Jan;27(1):1-4. doi: 10.1111/dote.12030. Epub 2013 Feb 6.
PubMed 23387392Kachaamy T, Lott D, Crujido LR, Rentz L, Fleischer D. Esophageal luminal restoration for a patient with a long lye-induced stricture via tunnel endoscopic therapy during a rendezvous procedure followed by self-dilation (with video). Gastrointest Endosc. 2014 Jul;80(1):192-4. doi: 10.1016/j.gie.2014.02.026. No abstract available.
PubMed 24950654Dzeletovic I, Fleischer DE. Self-dilation for resistant, benign esophageal strictures. Am J Gastroenterol. 2010 Oct;105(10):2142-3. doi: 10.1038/ajg.2010.212. No abstract available.
PubMed 20927061
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03738566
- Acronym / sponsor ID
- 18-000246
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Posted 24 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to see which treatment is more effective in improving the difficulty of swallowing. Researchers are comparing self-dilation to endoscopic dilation.
Detailed description
Benign esophageal strictures can be challenging condition to treat. The mainstay of treatment is endoscopic dilations. However, 30 to 40% of these strictures recur despite rigorous dilations. Although a consensus definition does not exist, a stricture is typically termed as a refractory benign esophageal stricture (RBES), when there is a failure to maintain luminal patency after at least 5 endoscopic dilations.
Patients with RBES are extremely difficult to manage and the current armamentarium includes repeated endoscopic dilations, corticosteroid or mitomycin C injections, incisional therapy, and/ or temporary stent placement. These procedures are costly, their efficacy can be short-lived, and are associated with great burden both for the patient and clinician.
Esophageal self -dilation therapy (ESDT) is where the patient learns to pass a polyvinyl dilator orally on a routine basis. In past, smaller studies, ESDT appears to be effective for RBES, reducing the number of endoscopic dilations from an average of 21.7 to an average of 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects who agreed to participate in the randomized trial were randomized to standard clinical care consisting of endoscopic dilation as needed versus esophageal self-dilation therapy in a 1:1 ratio using a block randomization approach. Subjects randomized to the standard clinical care group were offered cross-over to the esophageal self-dilation therapy if they failed stand of care. Subjects who agreed to take part in in the observational prospective study either commenced ESDT or continued standard clinical care based on shared decision making with their esophageal provider.
| Arm | Type | Receives |
|---|---|---|
| Standard Clinical Care Endoscopic Dilation Group | Active comparator | Procedure: Endoscopic therapy with esophageal dilationFollowing standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week. |
| Esophageal Self-Dilation Therapy (ESDT) Group | Active comparator | Device: Esophageal self-dilation therapyFollowing standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months. |
| Observational Study Group | Other | Device: Esophageal self-dilation therapy, Procedure: Endoscopic therapy with esophageal dilationSubjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider. |
| Standard Clinical Care Endoscopic Dilation, Then ESDT | Experimental | Device: Esophageal self-dilation therapy, Procedure: Endoscopic therapy with esophageal dilationSubjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Refractory benign esophageal stricture defined as an esophageal stricture with persistent dysphagia despite undergoing 5 endoscopic dilations within a 1 year period. Persistent dysphagia will be considered if patients has solid food dysphagia at least once a week
Key exclusion criteria (7 listed)
- Patient with malignant esophageal stricture
- Angulated stricture which prevents safe passage of Maloney dilator in office setting
- In ability to achieve an esophageal diameter of 10 mm with endoscopic dilation
- Known significant esophageal motor disorder (i.e. achalasia, aperistalsis, functional obstruction, jackhammer, distal esophageal spasm)*
- The presence of esophageal stent
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 |
|---|---|---|
| Esophageal self-dilation therapyAlso: ESDTPatient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week. | Device | Esophageal Self-Dilation Therapy (ESDT) Group, Observational Study Group, Standard Clinical Care Endoscopic Dilation, Then ESDT |
| Endoscopic therapy with esophageal dilationA long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched. | Procedure or surgery | Observational Study Group, Standard Clinical Care Endoscopic Dilation Group, Standard Clinical Care Endoscopic Dilation, Then ESDT |
Primary outcome
Number of Endoscopic Interventions
Time frame: 6 months following serial dilation
Number of endoscopies required in a 6 month interval in subjects who achieved at least a 10-12 mm esophageal diameter during serial dilation for refractory benign esophageal stricture (RBES) and were subsequently treated with ESDT versus standard clinical care
4 secondary outcomes
Length of Days Intervention Free
Time frame: 6 months
Mayo Dysphagia Questionnaire (MDQ-30) at Baseline
Time frame: Baseline
Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months
Time frame: 12 months
Clinically Significant Adverse Events
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10381932Spechler SJ. American gastroenterological association medical position statement on treatment of patients with dysphagia caused by benign disorders of the distal esophagus. Gastroenterology. 1999 Jul;117(1):229-33. doi: 10.1016/s0016-5085(99)70572-x.
- Background: PubMed 25019695Mendelson AH, Small AJ, Agarwalla A, Scott FI, Kochman ML. Esophageal anastomotic strictures: outcomes of endoscopic dilation, risk of recurrence and refractory stenosis, and effect of foreign body removal. Clin Gastroenterol Hepatol. 2015 Feb;13(2):263-271.e1. doi: 10.1016/j.cgh.2014.07.010. Epub 2014 Jul 11.
- Background: PubMed 22008891de Wijkerslooth LR, Vleggaar FP, Siersema PD. Endoscopic management of difficult or recurrent esophageal strictures. Am J Gastroenterol. 2011 Dec;106(12):2080-91; quiz 2092. doi: 10.1038/ajg.2011.348. Epub 2011 Oct 18.
- Background: PubMed 16111985Kochman ML, McClave SA, Boyce HW. The refractory and the recurrent esophageal stricture: a definition. Gastrointest Endosc. 2005 Sep;62(3):474-5. doi: 10.1016/j.gie.2005.04.050. No abstract available.
- Background: PubMed 16377340Hordijk ML, Siersema PD, Tilanus HW, Kuipers EJ. Electrocautery therapy for refractory anastomotic strictures of the esophagus. Gastrointest Endosc. 2006 Jan;63(1):157-63. doi: 10.1016/j.gie.2005.06.016.
- Background: PubMed 16279894Ramage JI Jr, Rumalla A, Baron TH, Pochron NL, Zinsmeister AR, Murray JA, Norton ID, Diehl N, Romero Y. A prospective, randomized, double-blind, placebo-controlled trial of endoscopic steroid injection therapy for recalcitrant esophageal peptic strictures. Am J Gastroenterol. 2005 Nov;100(11):2419-25. doi: 10.1111/j.1572-0241.2005.00331.x.
- Background: PubMed 19491851Eloubeidi MA, Lopes TL. Novel removable internally fully covered self-expanding metal esophageal stent: feasibility, technique of removal, and tissue response in humans. Am J Gastroenterol. 2009 Jun;104(6):1374-81. doi: 10.1038/ajg.2009.133. Epub 2009 Apr 28.
- Background: PubMed 20236257Repici A, Hassan C, Sharma P, Conio M, Siersema P. Systematic review: the role of self-expanding plastic stents for benign oesophageal strictures. Aliment Pharmacol Ther. 2010 Jun;31(12):1268-75. doi: 10.1111/j.1365-2036.2010.04301.x. Epub 2010 Mar 17.
- Background: PubMed 21034894Repici A, Vleggaar FP, Hassan C, van Boeckel PG, Romeo F, Pagano N, Malesci A, Siersema PD. Efficacy and safety of biodegradable stents for refractory benign esophageal strictures: the BEST (Biodegradable Esophageal Stent) study. Gastrointest Endosc. 2010 Nov;72(5):927-34. doi: 10.1016/j.gie.2010.07.031.
- Background: PubMed 26542391Nijhawan S, Udawat HP, Nagar P. Aggressive bougie dilatation and intralesional steroids is effective in refractory benign esophageal strictures secondary to corrosive ingestion. Dis Esophagus. 2016 Nov;29(8):1027-1031. doi: 10.1111/dote.12438. Epub 2015 Nov 6.
- Background: PubMed 26828759Repici A, Small AJ, Mendelson A, Jovani M, Correale L, Hassan C, Ridola L, Anderloni A, Ferrara EC, Kochman ML. Natural history and management of refractory benign esophageal strictures. Gastrointest Endosc. 2016 Aug;84(2):222-8. doi: 10.1016/j.gie.2016.01.053. Epub 2016 Jan 30.
- Background: PubMed 23925823Dzeletovic I, Fleischer DE, Crowell MD, Pannala R, Harris LA, Ramirez FC, Burdick GE, Rentz LA, Spratley RV Jr, Helling SD, Alexander JA. Self-dilation as a treatment for resistant, benign esophageal strictures. Dig Dis Sci. 2013 Nov;58(11):3218-23. doi: 10.1007/s10620-013-2822-7. Epub 2013 Aug 8.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Jeffrey Alexander, MD principal investigator
Mayo 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 Esophageal self-dilation therapy and Endoscopic therapy with esophageal dilation in people with Esophageal Dilation and Refractory Benign Esophageal Stricture, run by Mayo Clinic at 1 site in United States.
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 7 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 24 May 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 United States. 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?
Yes. Results are posted in the registry (first posted 24 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Endoscopic Interventions (time frame: 6 months following serial dilation). 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 NCT03738566, which also lists 20 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 24 May 2023.