Barrett EsophagusNCT07036432
Introduction of EndoSign ® in Management of Barrett's Oesophagus - a Swedish Feasibility Study
A study testing Endosign in people with Barrett Esophagus, run by Vastra Gotaland Region at 5 sites in Sweden.
Trial summary
This study is looking at a new way to detect and monitor Barrett's esophagus (BE), a condition where the lining of the esophagus changes, increasing the risk of esophageal cancer. Currently, monitoring involves an endoscopy, where a camera is passed down the throat. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Endosign
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 5 sitesSweden
- Study dates
- 1 Dec 2023to 1 Mar 2025
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a histopathologically confirmed diagnosis of Barrett's esophagus, specifically showing intestinal metaplasia.
- Patients must have at least a C0M1 Prague classification for their Barrett's esophagus.
- Patients must be under active monitoring with a surveillance endoscopy already planned to occur within the next 3 to 12 months.
- Patients must be between 18 and 84 years of age.
Who cannot join
- Patients scheduled for any endoscopic treatment (such as ablation) during their upcoming surveillance endoscopy.
- Patients experiencing alarm symptoms, including:
- Dysphagia (difficulty swallowing) and/or food sticking.
- Dyspepsia (indigestion) combined with weight loss.
- Dyspepsia combined with anaemia.
- Patients with a current diagnosis of an oropharyngeal, esophageal, or gastro-oesophageal tumour.
Show all 14Show fewer
- Patients who have received treatment to their esophagus (e.g., endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), radiofrequency ablation (RFA), or surgery) within the last two months.
- Patients known to have gastric or oesophageal varices or cirrhosis of the liver.
- Patients with any known anomaly of the oesophagus, such as webbing, pouches, or strictures.
- Patients who are unable to provide informed consent.
- Patients who have had a stroke or possess any other neurological disorder that has affected their swallowing ability.
- Patients who have experienced a myocardial infarction (heart attack) within the past 3 months.
- Patients who have undergone fundoplication or any other surgery involving the esophagus and proximal (upper) stomach.
- Patients currently using anti-trombotic medications which cannot be safely stopped temporarily for the procedure.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Sahlgrenska University Hospital
Gothenburg
Skåne University Hospital
Lund
Vrinnevi Hospital
Norrköping
Ersta Hospital
Stockholm
Karolinska University Hospital
Stockholm
About this study
This study is looking at a new way to detect and monitor Barrett's esophagus (BE), a condition where the lining of the esophagus changes, increasing the risk of esophageal cancer. Currently, monitoring involves an endoscopy, where a camera is passed down the throat. While effective, endoscopy can be uncomfortable, uses significant healthcare resources, and sometimes involves sedation.
This Swedish study explores a less invasive method called EndoSign®. EndoSign® is a small, swallowable capsule containing a sponge attached to a thin string. Patients swallow the capsule with water. It dissolves in the stomach over about 7 minutes, releasing the sponge. A trained nurse then gently pulls the sponge back up through the esophagus using the string, collecting cells along the way. The whole visit takes about 20-30 minutes. These cells are then sent to a lab to be checked for signs of BE and early changes (like TFF3, atypia, and p53) that might indicate a higher risk.
Read more
The main goals of this study are:
To see if using EndoSign® is practical (feasible) in several Swedish hospitals.
To find out how patients feel about the EndoSign® test - is it acceptable and comfortable?.
To check how safe the EndoSign® procedure is.
To gather information needed to plan larger studies in the future.
Who is participating? Around 70 adults (aged 18-84) across five Swedish hospitals, who have a confirmed diagnosis of BE and are already part of a surveillance program, are enrolled. Patients with certain alarm symptoms or those scheduled for immediate treatment are excluded.
What happens in the study? Participants have a separate visit for the EndoSign® test, performed by a trained nurse. They also undergo their regular surveillance endoscopy (at least 90 days after the capsule test). Participants fill out questionnaires about their experience, comfort, and preferences after both procedures and again at 7 and 90 days.
Potential Benefits \& Risks:
EndoSign® could offer a simpler, less invasive, and potentially more comfortable way to monitor BE, which might reduce the need for some endoscopies. Early results show it is well-tolerated, with most patients preferring it over endoscopy, and has a high success rate and safety profile. Risks are low, with the most common being a temporary sore throat. Serious complications are considered very rare.
This feasibility study aims to provide evidence on whether EndoSign® can be a valuable addition to BE surveillance in Sweden, potentially improving patient experience and resource use.
- Conditions
- Barrett Esophagus
- Being tested
- Endosign
- Keywords
- endosign, capsule sponge
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndosignDevice
The intervention involves the EndoSign® Cell collection device (Cyted Ltd), a non-endoscopic method for esophageal sampling.
Patients swallow a gelatine/HPMC capsule containing a sponge attached to a string. After ~7 minutes in the stomach for dissolution and sponge expansion, a trained nurse withdraws the sponge via the string, collecting cells. Optional throat anesthetic is offered.
It can be performed without sedation in an outpatient clinic setting by a nurse. Samples undergo central analysis for TFF3, atypia, and p53, differing from standard biopsy histopathology. This study specifically evaluates its feasibility, acceptability, and nurse-led implementation in Swedish hospitals for Barrett's surveillance.
| Study group | Role | What they receive |
|---|---|---|
| Endosign | Other | Not described Receives: Device: Endosign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success Rate of the EndoSign® Procedure
Measures the rate of successfully completed EndoSign® procedures. Technical success is defined as a participant successfully swallowing the capsule (in a maximum of two attempts) and subsequent successful retrieval of the sponge by the nurse.
Measured: Perioperative/Periprocedural
Patient-Reported Acceptability and Experience of the EndoSign® Procedure Compared to Gastroscopy
Measures and compares patient-reported outcomes for both the EndoSign® procedure and the surveillance gastroscopy. This includes Visual Analog Scale (VAS) scores (0-10) for discomfort and pain, which are measured immediately post-procedure and 15 minutes later for each respective procedure. It also assesses the patient's willingness to undergo each procedure again and their stated preference for future surveillance.
Patient willingness to undergo the EndoSign® procedure again. Patient preference for EndoSign® vs. endoscopy for future surveillance.
Measured: Perioperative/Periprocedural and at 7 and 90-day follow-ups. (Both Visits)
Safety of the EndoSign® Procedure
Incidence and rates of all Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) are recorded following the EndoSign® procedure. Events are classified by severity and relatedness.
Measured: Perioperative/Periprocedural and up to 90 days post-procedure.
Secondary outcomes (4)
Sample Adequacy of the EndoSign® Procedure
The proportion of retrieved EndoSign® samples are deemed adequate for full laboratory analysis, including TFF3 expression, atypia assessment, and p53 immunohistochemistry. An inadequate sample may be due to insufficient columnar cells or other factors preventing full analysis.
Measured: Perioperative/Periprocedural
Risk Stratification Performance of the EndoSign® Test
Evaluation of the EndoSign® test's ability (using TFF3, atypia, p53, and clinical factors) to classify patients into low, moderate, and high-risk groups for harboring dysplasia. This includes calculating metrics such as Negative Predictive Value (NPV) for no dysplasia in low/moderate-risk groups and Positive Predictive Value (PPV) for dysplasia in the high-risk group, by comparing with endoscopic biopsy findings.
Measured: Perioperative/Periprocedural
Assessment of Patient-Reported Health-Related Quality of Life using EQ-5D-5L
Measurement of general health-related quality of life using the EQ-5D-5L questionnaire, which assesses five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and includes a self-rated health Visual Analog Scale (VAS).
Measured: Perioperative/Periprocedural and at 7 and 90-day follow-ups.
EndoSign® Capsule Swallowing Attempts
The number of attempts required for patients to successfully swallow the EndoSign® capsule. Swallowing success contributes to the overall technical feasibility.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Dec 2023
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
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 Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036432
- Sponsor's protocol ID
- CIV-23-06-043373
- Status last verified
- Apr 2025
- First submitted
- 2 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lofdahl P, Elbe P, Thorell A, Jeremiasen M, Franzen T, Haas SL, Biorserud C, Bratlie SO. Introduction of a novel capsule sponge device for Barrett's surveillance - A Swedish multicenter feasibility study. Scand J Gastroenterol. 2026 Jun 4:1-9. doi: 10.1080/00365521.2026.2679097. Online ahead of print.
PubMed 42240428
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of EndoSign ® in Management of Barrett's Oesophagus - a Swedish Feasibility Study
- ClinicalTrials.gov ID
- NCT07036432
- Acronym / sponsor ID
- CIV-23-06-043373
- Conditions
- Barrett Esophagus
- Keywords
- endosign, capsule sponge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 25 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.
This study is looking at a new way to detect and monitor Barrett's esophagus (BE), a condition where the lining of the esophagus changes, increasing the risk of esophageal cancer. Currently, monitoring involves an endoscopy, where a camera is passed down the throat. While effective, endoscopy can be uncomfortable, uses significant healthcare resources, and sometimes involves sedation.
This Swedish study explores a less invasive method called EndoSign®. EndoSign® is a small, swallowable capsule containing a sponge attached to a thin string. Patients swallow the capsule with water. It dissolves in the stomach over about 7 minutes, releasing the sponge. A trained nurse then gently pulls the sponge back up through the esophagus using the string, collecting cells along the way. The whole visit takes about 20-30 minutes. These cells are then sent to a lab to be checked for signs of BE and early changes (like TFF3, atypia, and p53) that might indicate a higher risk.
The main goals of this study are:
To see if using EndoSign® is practical (feasible) in several Swedish hospitals.
To find out how patients feel about the EndoSign® test - is it acceptable and comfortable?.
To check how safe the EndoSign® procedure is.
To gather information needed to plan larger studies in the future.
Who is participating? Around 70 adults (aged 18-84) across five Swedish hospitals, who have a confirmed diagnosis of BE and are already part of a surveillance program, are enrolled. Patients with certain alarm symptoms or those scheduled for immediate treatment are excluded.
What happens in the study? Participants have a separate visit for the EndoSign® test, performed by a trained nurse. They also undergo their regular surveillance endoscopy (at least 90 days after the capsule test). Participants fill out questionnaires about their experience, comfort, and preferences after both procedures and again at 7 and 90 days.
Potential Benefits \& Risks:
EndoSign® could offer a simpler, less invasive, and potentially more comfortable way to monitor BE, which might reduce the need for some endoscopies. Early results show it is well-tolerated, with most patients preferring it over endoscopy, and has a high success rate and safety profile. Risks are low, with the most common being a temporary sore throat. Serious complications are considered very rare.
This feasibility study aims to provide evidence on whether EndoSign® can be a valuable addition to BE surveillance in Sweden, potentially improving patient experience and resource use.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endosign | Other | Device: Endosign |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must have a histopathologically confirmed diagnosis of Barrett's esophagus, specifically showing intestinal metaplasia.
- Patients must have at least a C0M1 Prague classification for their Barrett's esophagus.
- Patients must be under active monitoring with a surveillance endoscopy already planned to occur within the next 3 to 12 months.
- Patients must be between 18 and 84 years of age.
Key exclusion criteria (14 listed)
- Patients scheduled for any endoscopic treatment (such as ablation) during their upcoming surveillance endoscopy.
- Patients experiencing alarm symptoms, including:
- Dysphagia (difficulty swallowing) and/or food sticking.
- Dyspepsia (indigestion) combined with weight loss.
- Dyspepsia combined with anaemia.
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 |
|---|---|---|
| EndosignThe intervention involves the EndoSign® Cell collection device (Cyted Ltd), a non-endoscopic method for esophageal sampling. Patients swallow a gelatine/HPMC capsule containing a sponge attached to a string. After ~7 minutes in the stomach for dissolution and sponge expansion, a trained nurse withdraws the sponge via the string, collecting cells. Optional throat anesthetic is offered. It can be performed without sedation in an outpatient clinic setting by a nurse. Samples undergo central analysis for TFF3, atypia, and p53, differing from standard biopsy histopathology. This study specifically evaluates its feasibility, acceptability, and nurse-led implementation in Swedish hospitals for Barrett's surveillance. | Device | Endosign |
Primary outcome
Technical Success Rate of the EndoSign® Procedure
Time frame: Perioperative/Periprocedural
Measures the rate of successfully completed EndoSign® procedures. Technical success is defined as a participant successfully swallowing the capsule (in a maximum of two attempts) and subsequent successful retrieval of the sponge by the nurse.
Patient-Reported Acceptability and Experience of the EndoSign® Procedure Compared to Gastroscopy
Time frame: Perioperative/Periprocedural and at 7 and 90-day follow-ups. (Both Visits)
Measures and compares patient-reported outcomes for both the EndoSign® procedure and the surveillance gastroscopy. This includes Visual Analog Scale (VAS) scores (0-10) for discomfort and pain, which are measured immediately post-procedure and 15 minutes later for each respective procedure. It also assesses the patient's willingness to undergo each procedure again and their stated preference for future surveillance. Patient willingness to undergo the EndoSign® procedure again. Patient preference for EndoSign® vs. endoscopy for future surveillance.
Safety of the EndoSign® Procedure
Time frame: Perioperative/Periprocedural and up to 90 days post-procedure.
Incidence and rates of all Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) are recorded following the EndoSign® procedure. Events are classified by severity and relatedness.
4 secondary outcomes
Sample Adequacy of the EndoSign® Procedure
Time frame: Perioperative/Periprocedural
Risk Stratification Performance of the EndoSign® Test
Time frame: Perioperative/Periprocedural
Assessment of Patient-Reported Health-Related Quality of Life using EQ-5D-5L
Time frame: Perioperative/Periprocedural and at 7 and 90-day follow-ups.
EndoSign® Capsule Swallowing Attempts
Time frame: Perioperative/Periprocedural
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 25 Jun 2025.
- Derived from this study: PubMed 42240428Lofdahl P, Elbe P, Thorell A, Jeremiasen M, Franzen T, Haas SL, Biorserud C, Bratlie SO. Introduction of a novel capsule sponge device for Barrett's surveillance - A Swedish multicenter feasibility study. Scand J Gastroenterol. 2026 Jun 4:1-9. doi: 10.1080/00365521.2026.2679097. Online ahead of print.
Related trials for Barrett Esophagus
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 4
Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
Barrett Esophagus
RecruitingObservational study
"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
Barrett Esophagus, Barrett Esophagus Adenocarcinoma
Not yet recruitingObservational study
Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
RecruitingObservational study
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Dysplastic Barrett's Esophagus, Radiofrequency Ablation
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endosign in people with Barrett Esophagus, run by Vastra Gotaland Region at 5 sites in Sweden.
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 4 inclusion and 14 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 25 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 5 sites in Sweden. 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?
Technical Success Rate of the EndoSign® Procedure (time frame: Perioperative/Periprocedural). The study lists 3 primary outcomes in all. 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 NCT07036432, 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 25 Jun 2025.