Esophagogastric Junction DisorderEndoFLIPNCT04938102
Role of EndoFLIP in the Diagnostic Paradigm of Esophagogastric Junction Outflow Obstruction
A study testing Botulinum Toxin Type A Injection [Botox] in people with Esophagogastric Junction Disorder, run by University of Kansas Medical Center.
Trial summary
The aim of this project is to identify if EndoFLIP can categorize and change the diagnosis in patients with EGJOO and if categorization with EndoFLIP can predict the response to treatment with botulinum toxin at 12 weeks post procedure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophagogastric Junction Disorder
- What is being tested?
- Botulinum Toxin Type A Injection [Botox]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to 11 Oct 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosed with esophagogastric junction outflow obstruction by high resolution manometry
Who cannot join
- previous upper gastrointestinal surgery
- significant medical co-morbidities
- eosinophilic esophagitis
- severe reflux esophagitis (LA-classification C or D)
- large hiatal hernia
- patients experiencing significant weight loss suspicious for malignancy
- Vulnerable populations such as cognitively or decisionally impaired individuals, children, pregnant women, prisoners, and students or employees of the University of Kansas Health System or Medical Center
About this study
The aim of this project is to identify if EndoFLIP can categorize and change the diagnosis in patients with EGJOO and if categorization with EndoFLIP can predict the response to treatment with botulinum toxin at 12 weeks post procedure. Our hypothesis is that there will be greater symptom resolution in the treatment versus control in the abnormal DI category. In addition, we hypothesize there will be less symptom resolution in the control group with an abnormal DI as compared to those with a normal DI who also receive no treatment.
Read the detailed description
Esophagogastric Outflow Obstruction (EGJOO) is a newer diagnosis in which some patients' symptoms resolve spontaneously or with conservative treatment, while others require treatment with botulinum toxin injected into the lower esophageal sphincter. Currently, there is no way to distinguish these two groups of patients upon diagnosis. EndoFLIP (endolumenal functional lumen imaging probe) is a new technology that can measure the distensibility index (DI) of the lower esophageal sphincter. Data has suggested that normal and abnormal DI measurements can categorize these patients and guide treatment course (1). Our study looks to confirm this finding.
- Elsbernd et al. Clinical characteristics and treatment response of esophagogastric junction outflow obstruction. Gastroenterology 2019;156(6):S-1017.
- Conditions
- Esophagogastric Junction Disorder
- Being tested
- Botulinum Toxin Type A Injection [Botox]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A Injection [Botox]Drug
Injection of 100 units of botulinum toxin into the lower esophageal sphincter (25 units in each quadrant).
| Study group | Role | What they receive |
|---|---|---|
| Abnormal DI - Control | No intervention | Patients' whose distensibility index is measured <2.8 will receive no intervention. |
| Abnormal DI - Botox | Active comparator | Patients' whose distensibility index is measured <2.8 will be injected with 100 units of botulinum toxin in the lower esophageal sphincter (25 units in each quadrant). Receives: Drug: Botulinum Toxin Type A Injection [Botox] |
| Normal DI - Control | No intervention | Patients' whose distensibility index is measured >2.8 will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Resolution
The primary endpoint is the proportion of patients with complete symptom resolution at 12 weeks (Eckardt score < 3) post procedure in each group.
Measured: 12 weeks.
Secondary outcomes (2)
Percent change in symptom score
The secondary endpoint is the percent change in symptom score at 12 weeks in each group.
Measured: 12 weeks.
Mean symptom scores
The secondary endpoint is the change in mean symptom score in each group at 12 weeks.
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study startJul 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completion11 Oct 2024
Why it stopped: Administrative-not IRB approved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagogastric Junction DisorderStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reza Hejazi, University of Kansas Medical Center
- Investigators
- Reza Hejazi, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938102
- Sponsor's protocol ID
- STUDY00147450
- Acronym
- EndoFLIP
- Status last verified
- Oct 2024
- First submitted
- 21 Jun 2021
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of EndoFLIP in the Diagnostic Paradigm of Esophagogastric Junction Outflow Obstruction
- ClinicalTrials.gov ID
- NCT04938102
- Acronym / sponsor ID
- EndoFLIP / STUDY00147450
- Conditions
- Esophagogastric Junction Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative-not IRB approved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 24 Jun 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.
The aim of this project is to identify if EndoFLIP can categorize and change the diagnosis in patients with EGJOO and if categorization with EndoFLIP can predict the response to treatment with botulinum toxin at 12 weeks post procedure. Our hypothesis is that there will be greater symptom resolution in the treatment versus control in the abnormal DI category. In addition, we hypothesize there will be less symptom resolution in the control group with an abnormal DI as compared to those with a normal DI who also receive no treatment.
Detailed description
Esophagogastric Outflow Obstruction (EGJOO) is a newer diagnosis in which some patients' symptoms resolve spontaneously or with conservative treatment, while others require treatment with botulinum toxin injected into the lower esophageal sphincter. Currently, there is no way to distinguish these two groups of patients upon diagnosis. EndoFLIP (endolumenal functional lumen imaging probe) is a new technology that can measure the distensibility index (DI) of the lower esophageal sphincter. Data has suggested that normal and abnormal DI measurements can categorize these patients and guide treatment course (1). Our study looks to confirm this finding.
- Elsbernd et al. Clinical characteristics and treatment response of esophagogastric junction outflow obstruction. Gastroenterology 2019;156(6):S-1017.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Abnormal DI - Control | No intervention | –Patients' whose distensibility index is measured <2.8 will receive no intervention. |
| Abnormal DI - Botox | Active comparator | Drug: Botulinum Toxin Type A Injection [Botox]Patients' whose distensibility index is measured <2.8 will be injected with 100 units of botulinum toxin in the lower esophageal sphincter (25 units in each quadrant). |
| Normal DI - Control | No intervention | –Patients' whose distensibility index is measured >2.8 will receive no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed with esophagogastric junction outflow obstruction by high resolution manometry
Key exclusion criteria (7 listed)
- previous upper gastrointestinal surgery
- significant medical co-morbidities
- eosinophilic esophagitis
- severe reflux esophagitis (LA-classification C or D)
- large hiatal hernia
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 |
|---|---|---|
| Botulinum Toxin Type A Injection [Botox]Injection of 100 units of botulinum toxin into the lower esophageal sphincter (25 units in each quadrant). | Drug | Abnormal DI - Botox |
Primary outcome
Symptom Resolution
Time frame: 12 weeks.
The primary endpoint is the proportion of patients with complete symptom resolution at 12 weeks (Eckardt score < 3) post procedure in each group.
2 secondary outcomes
Percent change in symptom score
Time frame: 12 weeks.
Mean symptom scores
Time frame: 12 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- 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.
Reza Hejazi, MD principal investigator
University of Kansas Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin Type A Injection [Botox] in people with Esophagogastric Junction Disorder, run by University of Kansas Medical Center.
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: withdrawn, as of the sponsor's last update on 21 Oct 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Symptom Resolution (time frame: 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2024.