Benign Esophageal StrictureINTENSENCT07026357
Impact of 3D-planimetry on Optimized Therapeutic Assessment in Complex Benign Esophageal Stenosis
A study testing 3D-planimetric measurement in people with Benign Esophageal Stricture, run by Thomas Seufferlein at 1 site in Germany.
Trial summary
Esophageal stenosis has a high impact on patients quality of live and food intake affecting personal nutrition status and general health. For benign strictures of the esophagus, endoscopic dilatation therapy is recommended by actual guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Esophageal Stricture
- What is being tested?
- 3D-planimetric measurement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- 28 Dec 2022to 27 Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic benign esophageal stenosis
- medical indication for endoscopic therapy
- written consent after detailed information
Who cannot join
- non-benign esophageal stenosis
- missing written consent
- trans-oral endoscopic access is not possible
- medical contraindication for endoscopic dilatation therapy
- age <18 years
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Ulm, Clinic for Internal Medicine I
Ulm, Baden-Wuerttenberg, 89081
About this study
Official title: Impact of 3D-planimetry on Optimized Therapeutic Assessment in Complex Benign Esophageal Stenosis; a Prospective Multi-center Study
Esophageal stenosis has a high impact on patients quality of live and food intake affecting personal nutrition status and general health.
For benign strictures of the esophagus, endoscopic dilatation therapy is recommended by actual guidelines.
Since the extent of dilatation is currently directed by endoscopic view and fluoroscopic imaging, patients are exposed to radiation and the determination of the appropriate extent of dilatation is difficult.
Therefore, the aim of this study is to compare the effect of 3D-planimetric measurement with current fluoroscopic monitoring on the success of endoscopic esophageal dilatation therapy in patients with benign esophageal stenosis.
- Conditions
- Benign Esophageal Stricture
- Being tested
- 3D-planimetric measurement, Fluoroscopic control, Endoscopic control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-planimetric measurementDevice
Esophageal stenosis is evaluated by 3D-planimetric measurement
Fluoroscopic controlRadiation
Fluoroscopic control of dilatation therapy
Endoscopic controlDiagnostic test
Macroscopic endoscopic control of dilatation therapy
| Study group | Role | What they receive |
|---|---|---|
| 3D-planimetric Measurement | Experimental | Esophageal stenosis is measured and endoscopic therapy is controlled by 3D-planimetry in addition to the conventional method (fluoroscopy, endoscopic examination) Receives: Device: 3D-planimetric measurement; Radiation: Fluoroscopic control; Diagnostic Test: Endoscopic control |
| Conventional Measurement | Active comparator | Esophageal stenosis is measured and endoscopic therapy is controlled by fluoroscopy and endoscopic examination only Receives: Radiation: Fluoroscopic control; Diagnostic Test: Endoscopic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic therapy success
Change in esophageal diameter [mm] and length of esophageal stricture [cm] after endoscopic therapy
Measured: 3 months after intervention at endoscopic control examination
Secondary outcomes (9)
Length measurement of esophageal stenosis
Length measurement of esophageal stenosis by different methods [cm]
Measured: during endoscopic intervention
Postinterventional esophageal diameter
Postinterventional esophageal diameter [mm]
Measured: directly after endoscopic intervention
Hospitalization time after endoscopic dilatation therapy
Period of Hospitalization [days] after endoscopic dilatation therapy
Measured: within 3 months after study intervention
Number of endoscopic interventions
Number of endoscopic interventions after study intervention
Measured: within 3 months after study intervention
Number of hospitalizations due to complications
Hospitalization after study intervention [number of events, days] due to complications
Measured: within 3 months after initial study intervention
Quality of life assessed by German Sydney Swallow Questionnaire
Quality of life according to the German Sydney Swallow Questionnaire (G-SWAL-QoL) questionnaire [17 questions, minimum 0 to maximum 1700 points; higher score indicates higher impairment considering swallowing]
Measured: Baseline study intervention and 2 weeks after study intervention
Complication rate
Peri-procedural complication rate
Measured: during the procedure
Duration of endoscopic examination
Duration of endoscopic examination [minutes]
Measured: during the procedure
Sedation dose
Dose of sedative medication [mg] during study intervention
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start28 Dec 2022
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Esophageal StrictureStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Seufferlein
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen, University Hospital Augsburg, University Hospital Munich
- Responsible party
- Sponsor-investigator, Thomas Seufferlein, University of Ulm
- Investigators
- Benjamin Walter, PhD, Principal investigator, University Hospital Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026357
- Sponsor's protocol ID
- UL001
- Acronym
- INTENSE
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2022
- Last updated
- 18 Jun 2025
- 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 3D-planimetry on Optimized Therapeutic Assessment in Complex Benign Esophageal Stenosis; a Prospective Multi-center Study
- ClinicalTrials.gov ID
- NCT07026357
- Acronym / sponsor ID
- INTENSE / UL001
- Conditions
- Benign Esophageal Stricture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Thomas SeufferleinUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen, University Hospital Augsburg, University Hospital Munich
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 18 Jun 2025 (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.
Esophageal stenosis has a high impact on patients quality of live and food intake affecting personal nutrition status and general health.
For benign strictures of the esophagus, endoscopic dilatation therapy is recommended by actual guidelines.
Since the extent of dilatation is currently directed by endoscopic view and fluoroscopic imaging, patients are exposed to radiation and the determination of the appropriate extent of dilatation is difficult.
Therefore, the aim of this study is to compare the effect of 3D-planimetric measurement with current fluoroscopic monitoring on the success of endoscopic esophageal dilatation therapy in patients with benign esophageal stenosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-planimetric Measurement | Experimental | Device: 3D-planimetric measurement, Radiation: Fluoroscopic control, Diagnostic Test: Endoscopic controlEsophageal stenosis is measured and endoscopic therapy is controlled by 3D-planimetry in addition to the conventional method (fluoroscopy, endoscopic examination) |
| Conventional Measurement | Active comparator | Radiation: Fluoroscopic control, Diagnostic Test: Endoscopic controlEsophageal stenosis is measured and endoscopic therapy is controlled by fluoroscopy and endoscopic examination only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- symptomatic benign esophageal stenosis
- medical indication for endoscopic therapy
- written consent after detailed information
Key exclusion criteria (5 listed)
- non-benign esophageal stenosis
- missing written consent
- trans-oral endoscopic access is not possible
- medical contraindication for endoscopic dilatation therapy
- age <18 years
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 |
|---|---|---|
| 3D-planimetric measurementEsophageal stenosis is evaluated by 3D-planimetric measurement | Device | 3D-planimetric Measurement |
| Fluoroscopic controlFluoroscopic control of dilatation therapy | Radiation | 3D-planimetric Measurement, Conventional Measurement |
| Endoscopic controlMacroscopic endoscopic control of dilatation therapy | Diagnostic test | 3D-planimetric Measurement, Conventional Measurement |
Primary outcome
Endoscopic therapy success
Time frame: 3 months after intervention at endoscopic control examination
Change in esophageal diameter [mm] and length of esophageal stricture [cm] after endoscopic therapy
9 secondary outcomes
Length measurement of esophageal stenosis
Time frame: during endoscopic intervention
Postinterventional esophageal diameter
Time frame: directly after endoscopic intervention
Hospitalization time after endoscopic dilatation therapy
Time frame: within 3 months after study intervention
Number of endoscopic interventions
Time frame: within 3 months after study intervention
Number of hospitalizations due to complications
Time frame: within 3 months after initial study intervention
Quality of life assessed by German Sydney Swallow Questionnaire
Time frame: Baseline study intervention and 2 weeks after study intervention
Complication rate
Time frame: during the procedure
Duration of endoscopic examination
Time frame: during the procedure
Sedation dose
Time frame: during the procedure
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 18 Jun 2025.
- 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.
Benjamin Walter, PhD principal investigator
University Hospital Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-planimetric measurement in people with Benign Esophageal Stricture, run by Thomas Seufferlein at 1 site in Germany.
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 3 inclusion and 5 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 18 Jun 2025. 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 Germany. 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?
Endoscopic therapy success (time frame: 3 months after intervention at endoscopic control examination). 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 18 Jun 2025.