Benign Esophageal LesionsDESTINYNCT01337206
SX ELLA Esophageal Degradable BD Stent System
A study testing Stenting with ELLA Biodegradable stent and Standard Dilations in people with Benign Esophageal Lesions, run by Cook Group Incorporated at 8 sites in 5 countries.
Trial summary
The SX-ELLA Stent Esophageal Degradable BD (BD Stent) is designed for dilation of benign esophageal lesions, namely: (1) stenosis (peptic, anastomotic or caustic) refractory to standard therapy, (2) achalasia refractory to standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Esophageal Lesions
- What is being tested?
- Stenting with ELLA Biodegradable stent and Standard Dilations
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Jan 2012to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A recurrent benign esophageal stricture due to all causes (surgery, radiation therapy, corrosive ingestion, peptic injury, PDT, or other ablative therapy)
Who cannot join
- Patient < 18 years old
- Patient is unwilling or unable to sign and date the informed consent
- Patient is unwilling or unable to comply with the follow-up schedule
- Patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 months
- Patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study
- Patient with a life expectancy < 12 months
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Netherlands3 sites
Academic Medical Center
Amsterdam, 22700
St. Antonius Hospital
Nieuwegein
University Medical Center Utrech
Utrecht, 3508
Belgium2 sites
Clinique Universitaire Saint Luc
Brussels, 1000
University Hospitals Leuven
Leuven, 3000
United Kingdom1 site
University College of London Hospital
London, NW1 2PG
About this study
Official title: Evaluation of the Effectiveness of the SX ELLA Esophageal Degradable BD (BD Stent) Stent System
The SX-ELLA Stent Esophageal Degradable BD (BD Stent) is designed for dilation of benign esophageal lesions, namely: (1) stenosis (peptic, anastomotic or caustic) refractory to standard therapy, (2) achalasia refractory to standard therapy.
- Conditions
- Benign Esophageal Lesions
- Being tested
- Stenting with ELLA Biodegradable stent, Standard Dilations
- Keywords
- Esophageal Stenosis, Esopageal Strictures, Esophageal Dysphagia
- Medical subject headings
- Esophageal Stenosis, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stenting with ELLA Biodegradable stentDevice
Also called Esophageal Stenting
Treating benign esophageal lesions with the placement of a degradable stent
Standard DilationsProcedure or surgery
Also called Bougie Dilation, Balloon Dilation
Treating benign esophageal lesions with standard dilation therapy
| Study group | Role | What they receive |
|---|---|---|
| Stenting Arm | Experimental | Stenting Arm Receives: Device: Stenting with ELLA Biodegradable stent |
| Dilation Arm | Active comparator | Dilation Arm Receives: Procedure: Standard Dilations |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent
Measured: 3 - 6 months
Secondary outcomes (9)
Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion
Measured: 6 - 12 months
Time to recurrent significant dysphagia
Measured: 6 - 12 months
Time to dilation of recurrent stricture
Measured: 6 - 12 months
6 months and 12 months incidence of repeat dilation
Measured: 6 - 12 months
Serious and minor adverse events with possible or likely relation to the study Intervention
Measured: 6 - 12 months
Direct medicals costs: procedures, secondary interventions
Measured: 6 - 12 months
Quality of Life
Measured: 6 - 12 months
Technical success
Observing proper deployment and placement of stent using endoscopic and radiographic imaging.
Measured: 6 - 12 months
Assessment of presence of gold markers within the region of the esophagus at 3 months, if possible
Assessment of presence of gold markers within the region of the esophagus at 3 months, using radiographic imaging, if possible, to check for remaining sections of stent that have not yet degraded.
Measured: 6 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startJan 2012
- Primary completionJul 2014
- Study completionJan 2015
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 Benign Esophageal LesionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter D. Siersema, MD, PhD, Principal investigator, University Medical Center Utrech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337206
- Sponsor's protocol ID
- 09-024
- Acronym
- DESTINY
- Status last verified
- Feb 2015
- First submitted
- 13 Apr 2011
- Last updated
- 6 Feb 2015
- Results posted
- No
Publications
Walter D, van den Berg MW, Hirdes MM, Vleggaar FP, Repici A, Deprez PH, Viedma BL, Lovat LB, Weusten BL, Bisschops R, Haidry R, Ferrara E, Sanborn KJ, O'Leary EE, van Hooft JE, Siersema PD. Dilation or biodegradable stent placement for recurrent benign esophageal strictures: a randomized controlled trial. Endoscopy. 2018 Dec;50(12):1146-1155. doi: 10.1055/a-0602-4169. Epub 2018 Jun 8.
PubMed 29883979
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the SX ELLA Esophageal Degradable BD (BD Stent) Stent System
- ClinicalTrials.gov ID
- NCT01337206
- Acronym / sponsor ID
- DESTINY / 09-024
- Conditions
- Benign Esophageal Lesions
- Keywords
- Esophageal Stenosis, Esopageal Strictures, Esophageal Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Apr 2011 (estimated)
- 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.
The SX-ELLA Stent Esophageal Degradable BD (BD Stent) is designed for dilation of benign esophageal lesions, namely: (1) stenosis (peptic, anastomotic or caustic) refractory to standard therapy, (2) achalasia refractory to standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stenting Arm | Experimental | Device: Stenting with ELLA Biodegradable stentStenting Arm |
| Dilation Arm | Active comparator | Procedure: Standard DilationsDilation Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A recurrent benign esophageal stricture due to all causes (surgery, radiation therapy, corrosive ingestion, peptic injury, PDT, or other ablative therapy)
Key exclusion criteria (6 listed)
- Patient < 18 years old
- Patient is unwilling or unable to sign and date the informed consent
- Patient is unwilling or unable to comply with the follow-up schedule
- Patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 months
- Patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study
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 |
|---|---|---|
| Stenting with ELLA Biodegradable stentAlso: Esophageal StentingTreating benign esophageal lesions with the placement of a degradable stent | Device | Stenting Arm |
| Standard DilationsAlso: Bougie Dilation, Balloon DilationTreating benign esophageal lesions with standard dilation therapy | Procedure or surgery | Dilation Arm |
Primary outcome
The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent
Time frame: 3 - 6 months
9 secondary outcomes
Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion
Time frame: 6 - 12 months
Time to recurrent significant dysphagia
Time frame: 6 - 12 months
Time to dilation of recurrent stricture
Time frame: 6 - 12 months
6 months and 12 months incidence of repeat dilation
Time frame: 6 - 12 months
Serious and minor adverse events with possible or likely relation to the study Intervention
Time frame: 6 - 12 months
Direct medicals costs: procedures, secondary interventions
Time frame: 6 - 12 months
Quality of Life
Time frame: 6 - 12 months
Technical success
Time frame: 6 - 12 months
Assessment of presence of gold markers within the region of the esophagus at 3 months, if possible
Time frame: 6 - 12 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 6 Feb 2015.
- Derived from this study: PubMed 29883979Walter D, van den Berg MW, Hirdes MM, Vleggaar FP, Repici A, Deprez PH, Viedma BL, Lovat LB, Weusten BL, Bisschops R, Haidry R, Ferrara E, Sanborn KJ, O'Leary EE, van Hooft JE, Siersema PD. Dilation or biodegradable stent placement for recurrent benign esophageal strictures: a randomized controlled trial. Endoscopy. 2018 Dec;50(12):1146-1155. doi: 10.1055/a-0602-4169. Epub 2018 Jun 8.
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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.
Peter D. Siersema, MD, PhD principal investigator
University Medical Center Utrech
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stenting with ELLA Biodegradable stent and Standard Dilations in people with Benign Esophageal Lesions, run by Cook Group Incorporated at 8 sites in 5 countries.
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 6 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 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands, Belgium, Italy, Spain, United Kingdom. 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?
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?
The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent (time frame: 3 - 6 months). 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 NCT01337206, 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 6 Feb 2015.