Gastric NeoplasmsNCT02488746
Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)
An observational study of Gastric Neoplasms and Gastrointestinal Stromal Tumors, run by Kliniken Ludwigsburg-Bietigheim gGmbH at 1 site in Germany.
Trial summary
Prospective observational trial. A full thickness resection of gastric subepithelial tumors is performed after application of full thickness sutures underneath the tumor with the GERDX(TM) device. Hypothesis: This endoscopic method is feasible, effective and safe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Neoplasms, Gastrointestinal Stromal Tumors
- What is being tested?
- GERDX(TM)
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to Sep 2018
- 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: Patients in which a subepithelial gastric tumor has been detected (in our hospital, other hospitals or by transferring doctor).
Who may be able to join
- presence of a subepithelial gastric tumor with signs of potential malignancy in endoscopic ultrasound
- age 18 years or older
- participant has given informed consent
Who cannot join
- tumor size > 40 mm (endosonographic measurement) or large extramural tumor mass
- signs of systemic dissemination of tumor
- current presence of a different neoplastic disease (except after successful curative treatment without continued medication)
- former surgery or disease of esophagus or stomach that impedes insertion of the suturing device
- moribund patient
- limited possibility to give informed consent (e.g. language barrier, psychiatric disease)
- pregnancy and lactation period
Trial locations and contacts
1 site in 1 country.
About this study
Prospective observational trial. A full thickness resection of gastric subepithelial tumors is performed after application of full thickness sutures underneath the tumor with the GERDX(TM) device. Hypothesis: This endoscopic method is feasible, effective and safe.
- Conditions
- Gastric Neoplasms, Gastrointestinal Stromal Tumors
- Being tested
- GERDX(TM)
- Medical subject headings
- Stomach Neoplasms, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GERDX(TM)Device
Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.
| Study group | Role | What they receive |
|---|---|---|
| EFTR-GERDX | Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device. Receives: Device: GERDX(TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cases in which a complete macroscopic en bloc resection of the gastric subepithelial tumor could be achieved
Measured: intraoperative
Secondary outcomes (5)
Rate of cases in which a complete microscopic resection of the gastric subepithelial tumor could be achieved
Measured: within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
Rate of complications (bleeding, perforation)
Measured: 6 months after resection
Duration of hospitalization
Measured: within one week after resection
Number of participants with local or systemic recidive of tumor
Measured: 6 months after resection
Number of participants with needs of surgical therapy or endoscopic re-resection
Measured: 6 months after resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Why it stopped: According to study protocol the trial was terminated because the recruitment of trial participants was insufficient.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric NeoplasmsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karel Caca, Prof. Dr., Study chair, Klinikum Ludwigsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488746
- Sponsor's protocol ID
- FROST
- Status last verified
- Dec 2016
- First submitted
- 26 Jun 2015
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)
- ClinicalTrials.gov ID
- NCT02488746
- Acronym / sponsor ID
- FROST
- Conditions
- Gastric Neoplasms, Gastrointestinal Stromal Tumors
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: According to study protocol the trial was terminated because the recruitment of trial participants was insufficient.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbHUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 2 Jul 2015 (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.
Prospective observational trial. A full thickness resection of gastric subepithelial tumors is performed after application of full thickness sutures underneath the tumor with the GERDX(TM) device. Hypothesis: This endoscopic method is feasible, effective and safe.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EFTR-GERDX | – | Device: GERDX(TM)Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in which a subepithelial gastric tumor has been detected (in our hospital, other hospitals or by transferring doctor).
Key inclusion criteria (3 listed)
- presence of a subepithelial gastric tumor with signs of potential malignancy in endoscopic ultrasound
- age 18 years or older
- participant has given informed consent
Key exclusion criteria (7 listed)
- tumor size > 40 mm (endosonographic measurement) or large extramural tumor mass
- signs of systemic dissemination of tumor
- current presence of a different neoplastic disease (except after successful curative treatment without continued medication)
- former surgery or disease of esophagus or stomach that impedes insertion of the suturing device
- moribund patient
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 |
|---|---|---|
| GERDX(TM)Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device. | Device | EFTR-GERDX |
Primary outcome
Rate of cases in which a complete macroscopic en bloc resection of the gastric subepithelial tumor could be achieved
Time frame: intraoperative
5 secondary outcomes
Rate of cases in which a complete microscopic resection of the gastric subepithelial tumor could be achieved
Time frame: within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
Rate of complications (bleeding, perforation)
Time frame: 6 months after resection
Duration of hospitalization
Time frame: within one week after resection
Number of participants with local or systemic recidive of tumor
Time frame: 6 months after resection
Number of participants with needs of surgical therapy or endoscopic re-resection
Time frame: 6 months after resection
Results and safety
The study was stopped early (reason given: According to study protocol the trial was terminated because the recruitment of trial participants was insufficient.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 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.
Karel Caca, Prof. Dr. study chair
Klinikum Ludwigsburg
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 Gastric Neoplasms and Gastrointestinal Stromal Tumors, run by Kliniken Ludwigsburg-Bietigheim gGmbH at 1 site in Germany.
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 7 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: stopped early, as of the sponsor's last update on 9 Dec 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 Germany. 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 was stopped early (reason given: According to study protocol the trial was terminated because the recruitment of trial participants was insufficient.). Results are not available in the source record.
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?
Rate of cases in which a complete macroscopic en bloc resection of the gastric subepithelial tumor could be achieved (time frame: intraoperative). 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 9 Dec 2016.