Tumor SamplingNCT04519138
Investigation to Evaluate Safety and Efficacy of the Endodrill Model X Biopsy Instrument
A study testing Endodrill Model X and Fine-needle aspiration/biopsy in people with Tumor Sampling, run by Region Skane at 3 sites in Sweden.
Trial summary
This is an investigator led prospective open label investigation, performed at three clinics in Sweden, comparing the flexible endoscopic biopsy instrument Endodrill Model X with the standard sampling method endoscopic ultrasound fine needle aspiration/biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor Sampling
- What is being tested?
- Endodrill Model X and Fine-needle aspiration/biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesSweden
- Study dates
- 30 Sep 2020to 30 Nov 2021
- 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
- Adults at least 18 years of age at the day of inclusion
- Signed informed consent
- Submucosal tumor of the upper gastrointestinal tract with tumor size ≥ 10 mm, well localized by the endoscopic examination
Who cannot join
- Suspicion of vascular tumor (e.g. pulsating tumor)
- Ongoing treatment with anticoagulants (e.g. Warfarin)
- Ongoing treatment with immunosuppressive drugs
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Linköping University Hospital
Linköping, 581 85
Skane University Hospital
Lund, 251 87
Örebro University Hospital
Örebro, 701 85
About this study
Official title: Safety and Efficacy of the Endodrill Model X Biopsy Instrument When Sampling Tumours in the Upper Gastrointestinal Tract
This is an investigator led prospective open label investigation, performed at three clinics in Sweden, comparing the flexible endoscopic biopsy instrument Endodrill Model X with the standard sampling method endoscopic ultrasound fine needle aspiration/biopsy. Assessment of safety is the primary objective and performance is the secondary objective.
Read the detailed description
The investigation will include 20 patients with lesions and suspected tumors in the stomach, esophagus or duodenum (upper small intestine). The investigation will consist of one visit with an endoscopic examination with sampling of an observed lesion or suspected tumor. Six biopsies will be collected from each patient, three consecutive samples using the Endodrill Model X instrument and three consecutive samples using the standard fine needle. The order of instruments to be used will be randomly assigned. The patient will be under observation for 2 hours after the procedure. Telephone follow-up will be performed 1 and 7 days after the examination. Visual confirmation of the biopsies size will be recorded at the examination. If the samples verify a tumor or not will be evaluated at Day 14 when the pathology report is concluded.
- Conditions
- Tumor Sampling
- Being tested
- Endodrill Model X, Fine-needle aspiration/biopsy
- Keywords
- Endoscope, Gastrointestinal, Image-Guided Biopsy, Fine-Needle, Medical device, Methods, Diagnosis
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodrill Model XDevice
The investigational device Endodrill Model X is used for biopsy sampling in the upper gastrointestinal tract
Fine-needle aspiration/biopsyDevice
The standard method is used for biopsy sampling in the upper gastrointestinal tract
| Study group | Role | What they receive |
|---|---|---|
| Endodrill Model X | Experimental | Three consecutive samples will be taken using the Endodrill Model X instrument. Receives: Device: Endodrill Model X |
| Endoscopic ultrasound guided fine-needle aspiration/biopsy | Active comparator | Three consecutive samples will be taken using the the standard method fine-needle aspiration/biopsy. Receives: Device: Fine-needle aspiration/biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with pre-specified adverse events
Proportion of patients with one or more of the following: 1) non-intentional perforation of the sampled organ, 2) bleeding requiring open surgical intervention or treatment at an intensive care unit, 3) non-planned hospitalization for observation AND where the patient is not fully recovered within 10 days after the endoscopic examination
Measured: 10 days
Secondary outcomes (1)
Amount of visible biopsy material over or under 5 mm at endoscopy examination
Visual confirmation of the biopsies size > 5 mm or not, will be recorded at the examination. Analysis will be performed at each hospitals department of pathology as all biopsy samples are routinely handled. A copy of the pathology report will recorded in the Contact Report Form (CRF) at day 14 when the study report for each patient is concluded
Measured: Day 0 (day of biopsy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start30 Sep 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor SamplingStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Crossover
- Model description
- Both the Endodrill Model X device and the standard instrument are used on the same lesion and patient to evaluate both instruments and their functions under as similar circumstances as possible.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Bibb Instruments AB, Key2Compliance
- Responsible party
- Sponsor
- Investigators
- Fredrik Swahn, MD, PhD, Principal investigator, Skane University hospital, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519138
- Sponsor's protocol ID
- BIBB EDMX01
- Status last verified
- Nov 2021
- First submitted
- 17 Aug 2020
- Last updated
- 2 Dec 2021
- 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 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Endodrill Model X Biopsy Instrument When Sampling Tumours in the Upper Gastrointestinal Tract
- ClinicalTrials.gov ID
- NCT04519138
- Acronym / sponsor ID
- BIBB EDMX01
- Conditions
- Tumor Sampling
- Keywords
- Endoscope, Gastrointestinal, Image-Guided Biopsy, Fine-Needle, Medical device, Methods, Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Bibb Instruments AB, Key2Compliance
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 19 Aug 2020 (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 is an investigator led prospective open label investigation, performed at three clinics in Sweden, comparing the flexible endoscopic biopsy instrument Endodrill Model X with the standard sampling method endoscopic ultrasound fine needle aspiration/biopsy. Assessment of safety is the primary objective and performance is the secondary objective.
Detailed description
The investigation will include 20 patients with lesions and suspected tumors in the stomach, esophagus or duodenum (upper small intestine). The investigation will consist of one visit with an endoscopic examination with sampling of an observed lesion or suspected tumor. Six biopsies will be collected from each patient, three consecutive samples using the Endodrill Model X instrument and three consecutive samples using the standard fine needle. The order of instruments to be used will be randomly assigned. The patient will be under observation for 2 hours after the procedure. Telephone follow-up will be performed 1 and 7 days after the examination. Visual confirmation of the biopsies size will be recorded at the examination. If the samples verify a tumor or not will be evaluated at Day 14 when the pathology report is concluded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Both the Endodrill Model X device and the standard instrument are used on the same lesion and patient to evaluate both instruments and their functions under as similar circumstances as possible.
| Arm | Type | Receives |
|---|---|---|
| Endodrill Model X | Experimental | Device: Endodrill Model XThree consecutive samples will be taken using the Endodrill Model X instrument. |
| Endoscopic ultrasound guided fine-needle aspiration/biopsy | Active comparator | Device: Fine-needle aspiration/biopsyThree consecutive samples will be taken using the the standard method fine-needle aspiration/biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults at least 18 years of age at the day of inclusion
- Signed informed consent
- Submucosal tumor of the upper gastrointestinal tract with tumor size ≥ 10 mm, well localized by the endoscopic examination
Key exclusion criteria (4 listed)
- Suspicion of vascular tumor (e.g. pulsating tumor)
- Ongoing treatment with anticoagulants (e.g. Warfarin)
- Ongoing treatment with immunosuppressive drugs
- Pregnancy
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 |
|---|---|---|
| Endodrill Model XThe investigational device Endodrill Model X is used for biopsy sampling in the upper gastrointestinal tract | Device | Endodrill Model X |
| Fine-needle aspiration/biopsyThe standard method is used for biopsy sampling in the upper gastrointestinal tract | Device | Endoscopic ultrasound guided fine-needle aspiration/biopsy |
Primary outcome
Proportion of patients with pre-specified adverse events
Time frame: 10 days
Proportion of patients with one or more of the following: 1) non-intentional perforation of the sampled organ, 2) bleeding requiring open surgical intervention or treatment at an intensive care unit, 3) non-planned hospitalization for observation AND where the patient is not fully recovered within 10 days after the endoscopic examination
1 secondary outcome
Amount of visible biopsy material over or under 5 mm at endoscopy examination
Time frame: Day 0 (day of biopsy)
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 2 Dec 2021.
- 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.
Fredrik Swahn, MD, PhD principal investigator
Skane University hospital, Lund, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endodrill Model X and Fine-needle aspiration/biopsy in people with Tumor Sampling, run by Region Skane at 3 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 3 inclusion and 4 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 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Proportion of patients with pre-specified adverse events (time frame: 10 days). 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 2 Dec 2021.