Gastric DysplasiaPhase 4NCT01523912
Radiofrequency Ablation for the Treatment of Gastric Dysplasia
A Phase 4 study testing Radiofrequency ablation of dysplastic mucosa (HALO) in people with Gastric Dysplasia and Neoplasia, run by Hospital Sao Joao at 1 site in Portugal.
Trial summary
The finding of gastric dysplasia not associated with macroscopic lesions (DNAML) or the follow-up of dysplasia after endoscopic resection (DAER) is a challenging dilemma. In the last few years, radiofrequency ablation (RFA) has become a recognized tool in the treatment of dysplastic Barrett's esophagus, but its use in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Dysplasia, Neoplasia
- What is being tested?
- Radiofrequency ablation of dysplastic mucosa (HALO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2011to May 2015
- Phase
- Phase 4
- 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 dysplasia.
- The lesion is no larger than 5 cm in diameter.
- Age ≥ 18 years.
- 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
- Prior gastric irradiation or surgery.
- Anti-platelet or anti-thrombotic medication use that can not be stopped for 7 days before and after RFA.
- Gastric ulcers, fistulae, varices and malignancy.
- History of alcohol and/or controlled substance dependency.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ablation of Gastric Dysplastic Mucosa by a Novel Endoscopic Radiofrequency Device.
The finding of gastric dysplasia not associated with macroscopic lesions (DNAML) or the follow-up of dysplasia after endoscopic resection (DAER) is a challenging dilemma. In the last few years, radiofrequency ablation (RFA) has become a recognized tool in the treatment of dysplastic Barrett's esophagus, but its use in gastric dysplasia has not yet been studied. The investigators aim to study the efficacy, safety and tolerability of RFA in the treatment of dysplastic gastric mucosa.
Read the detailed description
Gastric cancer is the fourth most common cancer and the second leading cause of cancer related death worldwide. The 10-year survival of patients with this malignancy is 20% due to advanced disease at the time of diagnosis. Screening programs in countries with a high incidence of gastric neoplasia aim to detect early stage cancer, suitable for curative treatment. Well-differentiated dysplastic gastric lesions limited to the mucosa (when non-ulcerated or ulcerated and less than 3 cm) or limited to the superficial submucosa (when less than 3 cm and with no lymphatic or vascular invasion) have a negligible risk of lymph node metastasis and are suitable for endoscopic curative treatment.
Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) have been increasingly used in this setting with promising results. However, even with these advanced techniques, en bloc and R0 resection is not possible in up to 13-15% and 16-26% of the cases, respectively. The presence of dysplasia after endoscopic resection (DAER) in the post-resection scar presents a challenging dilemma due to the technical difficulty, and associated complications, of performing subsequent EMR/ESD in fibrotic tissue. Another issue of concern is the presence of gastric dysplasia not associated with macroscopic lesions (DNAML). In such cases, a targeted endoscopic treatment is difficult and clinical management is not standardized.
Radiofrequency ablation (RFA) has been increasingly advocated for the treatment of dysplastic Barrett's esophagus (BE) and early esophageal squamous cell carcinoma (ESCC), but its use in gastric dysplasia has not yet been tested. The investigators aim to study the role of gastric RFA in the treatment of DNAML and DAER.
- Conditions
- Gastric Dysplasia, Neoplasia
- Being tested
- Radiofrequency ablation of dysplastic mucosa (HALO)
- Keywords
- radiofrequency ablation, gastric dysplasia, gastric neoplasia
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation of dysplastic mucosa (HALO)Device
Also called Halo, RFA
Gastric ablation is performed using the HALO Ablation System (BÂRRX Medical Inc., Sunnyvale, CA, USA). A HALO90 ablation catheter, which is mounted on the tip of an endoscope, is used. Radiofrequency energy is delivered at 40 W/cm2 and 15 J/cm2 via a 13 x 20 mm electrode. All patients will have two RFA sessions 8 weeks apart with the same area being ablated in consecutive endoscopies. The precise area to ablated in the second RFA session is determined by referring to careful measurements that utilized gastric landmarks (a typical notation may specify that the lesion extends from 2 to 5 cm proximal of the pylorus in the 5 o'clock position and is 4 cm wide) as well as to digital image recordings that are taken during the first RFA.
| Study group | Role | What they receive |
|---|---|---|
| gastric RFA | Experimental | Ablation of gastric dysplastic mucosa Receives: Device: Radiofrequency ablation of dysplastic mucosa (HALO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The % of patients with complete histological clearance of dysplasia.
Measured: 12 months
Secondary outcomes (2)
Histological clearance of intestinal metaplasia
Measured: 12 months
Adverse event incidence
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric DysplasiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Joao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Baldaque-Silva, Hospital Sao Joao
- Investigators
- Francisco Baldaque-Silva, MD, Principal investigator, Hospital Sao Joao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523912
- Sponsor's protocol ID
- gastric ablation
- Other IDs
- SG.HSJ.FMUP.01.2012
- Status last verified
- Feb 2016
- First submitted
- 25 Jan 2012
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation of Gastric Dysplastic Mucosa by a Novel Endoscopic Radiofrequency Device.
- ClinicalTrials.gov ID
- NCT01523912
- Acronym / sponsor ID
- gastric ablation
- Conditions
- Gastric Dysplasia, Neoplasia
- Keywords
- radiofrequency ablation, gastric dysplasia, gastric neoplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital Sao JoaoUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 Feb 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.
The finding of gastric dysplasia not associated with macroscopic lesions (DNAML) or the follow-up of dysplasia after endoscopic resection (DAER) is a challenging dilemma. In the last few years, radiofrequency ablation (RFA) has become a recognized tool in the treatment of dysplastic Barrett's esophagus, but its use in gastric dysplasia has not yet been studied. The investigators aim to study the efficacy, safety and tolerability of RFA in the treatment of dysplastic gastric mucosa.
Detailed description
Gastric cancer is the fourth most common cancer and the second leading cause of cancer related death worldwide. The 10-year survival of patients with this malignancy is 20% due to advanced disease at the time of diagnosis. Screening programs in countries with a high incidence of gastric neoplasia aim to detect early stage cancer, suitable for curative treatment. Well-differentiated dysplastic gastric lesions limited to the mucosa (when non-ulcerated or ulcerated and less than 3 cm) or limited to the superficial submucosa (when less than 3 cm and with no lymphatic or vascular invasion) have a negligible risk of lymph node metastasis and are suitable for endoscopic curative treatment.
Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) have been increasingly used in this setting with promising results. However, even with these advanced techniques, en bloc and R0 resection is not possible in up to 13-15% and 16-26% of the cases, respectively. The presence of dysplasia after endoscopic resection (DAER) in the post-resection scar presents a challenging dilemma due to the technical difficulty, and associated complications, of performing subsequent EMR/ESD in fibrotic tissue. Another issue of concern is the presence of gastric dysplasia not associated with macroscopic lesions (DNAML). In such cases, a targeted endoscopic treatment is difficult and clinical management is not standardized.
Radiofrequency ablation (RFA) has been increasingly advocated for the treatment of dysplastic Barrett's esophagus (BE) and early esophageal squamous cell carcinoma (ESCC), but its use in gastric dysplasia has not yet been tested. The investigators aim to study the role of gastric RFA in the treatment of DNAML and DAER.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastric RFA | Experimental | Device: Radiofrequency ablation of dysplastic mucosa (HALO)Ablation of gastric dysplastic mucosa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological confirmation of gastric dysplasia.
- The lesion is no larger than 5 cm in diameter.
- Age ≥ 18 years.
- 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.
Key exclusion criteria (5 listed)
- Prior gastric irradiation or surgery.
- Anti-platelet or anti-thrombotic medication use that can not be stopped for 7 days before and after RFA.
- Gastric ulcers, fistulae, varices and malignancy.
- History of alcohol and/or controlled substance dependency.
- 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 |
|---|---|---|
| Radiofrequency ablation of dysplastic mucosa (HALO)Also: Halo, RFAGastric ablation is performed using the HALO Ablation System (BÂRRX Medical Inc., Sunnyvale, CA, USA). A HALO90 ablation catheter, which is mounted on the tip of an endoscope, is used. Radiofrequency energy is delivered at 40 W/cm2 and 15 J/cm2 via a 13 x 20 mm electrode. All patients will have two RFA sessions 8 weeks apart with the same area being ablated in consecutive endoscopies. The precise area to ablated in the second RFA session is determined by referring to careful measurements that utilized gastric landmarks (a typical notation may specify that the lesion extends from 2 to 5 cm proximal of the pylorus in the 5 o'clock position and is 4 cm wide) as well as to digital image recordings that are taken during the first RFA. | Device | gastric RFA |
Primary outcome
The % of patients with complete histological clearance of dysplasia.
Time frame: 12 months
2 secondary outcomes
Histological clearance of intestinal metaplasia
Time frame: 12 months
Adverse event incidence
Time frame: 60 days
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 22 Feb 2016.
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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.
Francisco Baldaque-Silva, MD principal investigator
Hospital Sao Joao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Radiofrequency ablation of dysplastic mucosa (HALO) in people with Gastric Dysplasia and Neoplasia, run by Hospital Sao Joao at 1 site in Portugal.
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 5 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 22 Feb 2016. 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 Portugal. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The % of patients with complete histological clearance of dysplasia. (time frame: 12 months). 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 22 Feb 2016.