Gastric DysplasiaPhase 1/2NCT01614418
Radiofrequency Ablation for Gastric Metaplasia and Dysplasia
A Phase 1/2 study testing Endoscopic radiofrequency ablation catheter in people with Gastric Dysplasia and Intestinal Metaplasia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Gastric intestinal metaplasia (IM) and dysplasia, also referred to as intra-epithelial neoplasia, are well recognized precursors of gastric cancer. Apart from endoscopic surveillance, there is no other intervention which predictably eradicates pre-cancerous gastric lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Dysplasia, Intestinal Metaplasia
- What is being tested?
- Endoscopic radiofrequency ablation catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2011to Dec 2013
- Phase
- Phase 1/2
- 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
- Histological confirmation of gastric IM or dysplasia.
- The lesion is no larger than 5 cm in diameter.
- Age ≥ 18 years.
- No previous endoscopic mucosal resection or submucosal dissection.
- No active H. pylori infection.
- Subject is able to tolerate endoscopy and sedation.
- Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form.
Who cannot join
- Gastric cancer (intra-mucosal cancer or worse).
- Prior gastric irradiation or surgery.
- Anti-platelet or anti-thrombotic medication use that cannot be stopped for 7 days before and after RFA.
- Gastric ulcers, fistulae and varices.
- History of alcohol and/or controlled substance dependency.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Radiofrequency Ablation for Gastric Metaplasia and Dysplasia
Gastric intestinal metaplasia (IM) and dysplasia, also referred to as intra-epithelial neoplasia, are well recognized precursors of gastric cancer. Apart from endoscopic surveillance, there is no other intervention which predictably eradicates pre-cancerous gastric lesions.
Endoscopic radiofrequency ablative (RFA) therapy has been recently shown to be highly effective in eradicating both IM and dysplasia in patients with Barrett's esophagus. However, the potential role of RFA to remove gastric IM and dysplasia remains unknown. In this study, we determine the feasibility of using endoscopic RFA in treating early gastric neoplasia (metaplasia and dysplasia). Patients with gastric metaplasia and/or dysplasia will be treated with endoscopic RFA. The safety and effects of RFA will be determined.
- Conditions
- Gastric Dysplasia, Intestinal Metaplasia
- Being tested
- Endoscopic radiofrequency ablation catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic radiofrequency ablation catheterDevice
Also called BARRX HALO90
Endoscopic radiofrequency ablation
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic radiofrequency ablation | Experimental | Endoscopic radiofrequency ablation using BARRX HALO90 catheter Receives: Device: Endoscopic radiofrequency ablation catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological clearance of dysplasia/metaplasia
Measured: 6 month
Secondary outcomes (1)
Number of Participants with Adverse Events
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2013
- Study completionDec 2013
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 Gastric DysplasiaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEUNG Wai Keung, The University of Hong Kong
- Investigators
- Wai Keung Leung, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614418
- Sponsor's protocol ID
- HKU_WKL_RFA1
- Status last verified
- Dec 2013
- First submitted
- 4 Jun 2012
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Leung WK, Tong DK, Leung SY, Chan FS, Tong TS, Ho RS, Chu KM, Law SY. Treatment of Gastric Metaplasia or Dysplasia by Endoscopic Radiofrequency Ablation: A Pilot Study. Hepatogastroenterology. 2015 May;62(139):748-51.
PubMed 26897966
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Radiofrequency Ablation for Gastric Metaplasia and Dysplasia
- ClinicalTrials.gov ID
- NCT01614418
- Acronym / sponsor ID
- HKU_WKL_RFA1
- Conditions
- Gastric Dysplasia, Intestinal Metaplasia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Jun 2012 (estimated)
- 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.
Gastric intestinal metaplasia (IM) and dysplasia, also referred to as intra-epithelial neoplasia, are well recognized precursors of gastric cancer. Apart from endoscopic surveillance, there is no other intervention which predictably eradicates pre-cancerous gastric lesions.
Endoscopic radiofrequency ablative (RFA) therapy has been recently shown to be highly effective in eradicating both IM and dysplasia in patients with Barrett's esophagus. However, the potential role of RFA to remove gastric IM and dysplasia remains unknown. In this study, we determine the feasibility of using endoscopic RFA in treating early gastric neoplasia (metaplasia and dysplasia). Patients with gastric metaplasia and/or dysplasia will be treated with endoscopic RFA. The safety and effects of RFA will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic radiofrequency ablation | Experimental | Device: Endoscopic radiofrequency ablation catheterEndoscopic radiofrequency ablation using BARRX HALO90 catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological confirmation of gastric IM or dysplasia.
- The lesion is no larger than 5 cm in diameter.
- Age ≥ 18 years.
- No previous endoscopic mucosal resection or submucosal dissection.
- No active H. pylori infection.
Key exclusion criteria (6 listed)
- Gastric cancer (intra-mucosal cancer or worse).
- Prior gastric irradiation or surgery.
- Anti-platelet or anti-thrombotic medication use that cannot be stopped for 7 days before and after RFA.
- Gastric ulcers, fistulae and varices.
- History of alcohol and/or controlled substance dependency.
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 radiofrequency ablation catheterAlso: BARRX HALO90Endoscopic radiofrequency ablation | Device | Endoscopic radiofrequency ablation |
Primary outcome
Histological clearance of dysplasia/metaplasia
Time frame: 6 month
1 secondary outcome
Number of Participants with Adverse Events
Time frame: up to 6 month
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 19 Dec 2013.
- Derived from this study: PubMed 26897966Leung WK, Tong DK, Leung SY, Chan FS, Tong TS, Ho RS, Chu KM, Law SY. Treatment of Gastric Metaplasia or Dysplasia by Endoscopic Radiofrequency Ablation: A Pilot Study. Hepatogastroenterology. 2015 May;62(139):748-51.
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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.
Wai Keung Leung, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Endoscopic radiofrequency ablation catheter in people with Gastric Dysplasia and Intestinal Metaplasia, run by The University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 6 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 19 Dec 2013. 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 Hong Kong. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Histological clearance of dysplasia/metaplasia (time frame: 6 month). 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 NCT01614418, 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 19 Dec 2013.