Presence of Spot Ex Endoscopic MarkerSpot Ex PMCFNCT07206615
Spot Ex PMCF 01 Study
An observational study of Presence of Spot Ex Endoscopic Marker, run by Laborie Medical Technologies Inc. at 1 site in United States.
Trial summary
Post market clinical study that is a chart review of the Spot Ex Endoscopic Marker Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presence of Spot Ex Endoscopic Marker
- What is being tested?
- Endoscopic marker
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 21 Aug 2026
- Phase
- Observational
- 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
Study population: 60 subjects with visual confirmation of the presence of Spot Ex as visualized by a clinician or in colonoscopy imaging at 36 months. Additional subjects may be screened to reach the minimum sample size required (60 subjects).
Who may be able to join
- Patients who had a marking in their GI tract with the Spot Ex Endoscopic marker for the purposes of clinical surveillance.
Who cannot join
- 1. Patients who had the marked tissue resected less than 3 years after initial marking.
- 2. Inadequate medical documentation to ascertain visualization of the marking.
- 3. Inability to visualize or image the marking due to poor colonoscopy preparation.
- 4. Patients considered as Vulnerable Populations, as defined in CFR - Code of Federal Regulations Title 21
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Post Market Clinical Follow-Up Study - Chart Review of the Spot Ex Endoscopic Marker
Post market clinical study that is a chart review of the Spot Ex Endoscopic Marker
Read the detailed description
This study is a medical chart review to confirm the safety and performance of the Spot Ex Endoscopic Marker in accordance with the approved labelling/instructions for use (IFU).
- Conditions
- Presence of Spot Ex Endoscopic Marker
- Being tested
- Endoscopic marker
- Keywords
- Spot Ex, Endoscopic Marker, Laborie
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic markerOther
Study to confirm the safety and performance of the Laborie Spot Ex Endoscopic Marker in accordance with the approved labelling/instructions for use (IFU).
| Study group | Role | What they receive |
|---|---|---|
| Spot Ex Endoscopic Marker | Subjects with Spot Ex Endoscopic Marker present 36 months post-tattoo Receives: Other: Endoscopic marker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longevity
Visual confirmation at 36 months - Percent of subjects with visual confirmation of the presence of Spot Ex as visualized by a clinician or in colonoscopy imaging at 36 months.
Measured: From endoscopic marker placement date to 36 months post-tattoo date
Secondary outcomes (1)
Safety Endpoint
Percent of treatment-related adverse events specified in the protocol.
Measured: From endoscopic marker placement date to 36 months post-tattoo date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Oct 2025
- Primary completion21 Aug 2026
- Study completion21 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Presence of Spot Ex Endoscopic MarkerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laborie Medical Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206615
- Sponsor's protocol ID
- CLN-00082
- Acronym
- Spot Ex PMCF
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study - Chart Review of the Spot Ex Endoscopic Marker
- ClinicalTrials.gov ID
- NCT07206615
- Acronym / sponsor ID
- Spot Ex PMCF / CLN-00082
- Conditions
- Presence of Spot Ex Endoscopic Marker
- Keywords
- Spot Ex, Endoscopic Marker, Laborie
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Laborie Medical Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 21 Aug 2026 (actual)
- Study completion
- 21 Aug 2026 (actual)
- First posted
- 3 Oct 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.
Post market clinical study that is a chart review of the Spot Ex Endoscopic Marker
Detailed description
This study is a medical chart review to confirm the safety and performance of the Spot Ex Endoscopic Marker in accordance with the approved labelling/instructions for use (IFU).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spot Ex Endoscopic Marker | – | Other: Endoscopic markerSubjects with Spot Ex Endoscopic Marker present 36 months post-tattoo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 subjects with visual confirmation of the presence of Spot Ex as visualized by a clinician or in colonoscopy imaging at 36 months. Additional subjects may be screened to reach the minimum sample size required (60 subjects).
Key inclusion criteria (1 listed)
- Patients who had a marking in their GI tract with the Spot Ex Endoscopic marker for the purposes of clinical surveillance.
Key exclusion criteria (4 listed)
- 1. Patients who had the marked tissue resected less than 3 years after initial marking.
- 2. Inadequate medical documentation to ascertain visualization of the marking.
- 3. Inability to visualize or image the marking due to poor colonoscopy preparation.
- 4. Patients considered as Vulnerable Populations, as defined in CFR - Code of Federal Regulations Title 21
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 |
|---|---|---|
| Endoscopic markerStudy to confirm the safety and performance of the Laborie Spot Ex Endoscopic Marker in accordance with the approved labelling/instructions for use (IFU). | Other | Spot Ex Endoscopic Marker |
Primary outcome
Longevity
Time frame: From endoscopic marker placement date to 36 months post-tattoo date
Visual confirmation at 36 months - Percent of subjects with visual confirmation of the presence of Spot Ex as visualized by a clinician or in colonoscopy imaging at 36 months.
1 secondary outcome
Safety Endpoint
Time frame: From endoscopic marker placement date to 36 months post-tattoo date
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 Aug 2026.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Presence of Spot Ex Endoscopic Marker, run by Laborie Medical Technologies Inc. at 1 site in United States.
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 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 25 Aug 2026. 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 United States. 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?
Longevity (time frame: From endoscopic marker placement date to 36 months post-tattoo date). 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 25 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.