Large Polyps in the Gastrointestinal TractPhase 2NCT00583466
Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection
A Phase 2 study testing Autologous blood injection, Normal saline and HPMC in people with Large Polyps in the Gastrointestinal Tract, run by Johns Hopkins University at 1 site in United States.
Trial summary
For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Large Polyps in the Gastrointestinal Tract
- What is being tested?
- Autologous blood injection, Normal saline and HPMC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to May 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Polyps equal or larger than 1 cm
Who cannot join
- Coagulopathy
- Inability to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation.
Read the detailed description
For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators decided to use blood drawn from the patient for injection under the lesion. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation. Blood can also have local hemostatic action preventing from bleeding during polypectomy.
- Being tested
- Autologous blood injection, Normal saline, HPMC
- Keywords
- submucosal cushion, polypectomy, endoscopic mucosal resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous blood injectionDrug
Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion
Normal salineDrug
Normal saline will be injected under the lesion to create submucosal cushion
HPMCDrug
Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion
| Study group | Role | What they receive |
|---|---|---|
| 1 Normal saline arm | Active comparator | Polypectomy with normal saline injected for submucosal cushion creation Receives: Drug: Normal saline |
| 2 HPMC arm | Active comparator | Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion Receives: Drug: HPMC |
| 3 Blood arm | Experimental | Polypectomy after injection of autologous blood Receives: Drug: Autologous blood injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the Submucosal Cushion
Measured: Immediately after the procedure, Up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Large Polyps in the Gastrointestinal TractStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergey V. Kantsevoy, M.D., Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583466
- Sponsor's protocol ID
- NA_00008376
- Status last verified
- Sep 2017
- First submitted
- 20 Dec 2007
- Last updated
- 13 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Giday SA, Magno P, Buscaglia JM, Canto MI, Ko CW, Shin EJ, Xia L, Wroblewski LM, Clarke JO, Kalloo AN, Jagannath SB, Kantsevoy SV. Is blood the ideal submucosal cushioning agent? A comparative study in a porcine model. Endoscopy. 2006 Dec;38(12):1230-4. doi: 10.1055/s-2006-944971.
PubMed 17163324
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection
- ClinicalTrials.gov ID
- NCT00583466
- Acronym / sponsor ID
- NA_00008376
- Keywords
- submucosal cushion, polypectomy, endoscopic mucosal resection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- May 2007 (actual)
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 31 Dec 2007 (estimated)
- Results
- Posted 13 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation.
Detailed description
For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators decided to use blood drawn from the patient for injection under the lesion. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation. Blood can also have local hemostatic action preventing from bleeding during polypectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Normal saline arm | Active comparator | Drug: Normal salinePolypectomy with normal saline injected for submucosal cushion creation |
| 2 HPMC arm | Active comparator | Drug: HPMCPolypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion |
| 3 Blood arm | Experimental | Drug: Autologous blood injectionPolypectomy after injection of autologous blood |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Polyps equal or larger than 1 cm
Key exclusion criteria (2 listed)
- Coagulopathy
- Inability to sign informed consent
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 |
|---|---|---|
| Autologous blood injectionAutologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion | Drug | 3 Blood arm |
| Normal salineNormal saline will be injected under the lesion to create submucosal cushion | Drug | 1 Normal saline arm |
| HPMCHydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion | Drug | 2 HPMC arm |
Primary outcome
Duration of the Submucosal Cushion
Time frame: Immediately after the procedure, Up to 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17163324Giday SA, Magno P, Buscaglia JM, Canto MI, Ko CW, Shin EJ, Xia L, Wroblewski LM, Clarke JO, Kalloo AN, Jagannath SB, Kantsevoy SV. Is blood the ideal submucosal cushioning agent? A comparative study in a porcine model. Endoscopy. 2006 Dec;38(12):1230-4. doi: 10.1055/s-2006-944971.
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Colorectal Cancer (CRC), Colorectal Cancer and Pre-cancer Polyps
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.
Sergey V. Kantsevoy, M.D., Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous blood injection, Normal saline and HPMC in people with Large Polyps in the Gastrointestinal Tract, run by Johns Hopkins University 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 2 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 13 Sep 2017. 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.
What does this phase mean?
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?
Yes. Results are posted in the registry (first posted 13 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Duration of the Submucosal Cushion (time frame: Immediately after the procedure, Up to 5 minutes). 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 NCT00583466, 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 13 Sep 2017.