An interventional study of HALO90 Ablation catheter in Pelvic Neoplasms, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-05.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Treatment
Among 28 studies in Pelvic Neoplasms with a site in United States — 5 open to participants now, 9 under way, 2 of them phase 3. Pelvic Neoplasms · United States.
Among the 28 studies in Pelvic Neoplasms with a site in United States, this one is the 20th largest by enrollment of the 20 interventional ones that give a count, is the only one that started in 2008, is one of 8 with no phase, and was the 9th registered.
82 studies on the registry are indexed under Pelvic Neoplasms; 28 are open to participants now.
Browse Pelvic Neoplasms studies →5 of the 28 studies in Pelvic Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Duke University · Sites in United States
Ages 18+ · Women only
Mayo Clinic · Sites in United States
Ages 6 mo–17 yrs
University of California, San Diego · Sites in United States
Ages 18+
M.D. Anderson Cancer Center · Sites in United States
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 23 Pelvic Neoplasms studies recruiting now, 16 (70%) set no upper age limit and 3 (13%) stop at 75 or younger; 5 take children under 18; none take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
28 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2008.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1 is below the median of 47 across 50 interventional studies indexed under Pelvic Neoplasms.
Median enrollment 38 across the 20 interventional studies, 87 across the 8 observational. Of the 19 that completed or were terminated, 5 (26%) have results posted.
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7 of 28 have an industry lead sponsor. The 10 most frequent:
University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
University Hospitals Cleveland Medical Center has 1 study filed under Pelvic Neoplasms — fewer than ten, so there is no comparison to draw.
2 of the studies in Pelvic Neoplasms with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06915727Phase 3Mayo ClinicAn Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors | 2027-05-01 |
| NCT05134142M.D. Anderson Cancer CenterQuality of Life and Function of Patients With Pelvic Tumors After Undergoing Hemipelvectomy | 2027-04-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 28 studies in Pelvic Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study involves evaluating a procedure in which the study device, the HALO90 Ablation catheter, is used to heat a thin layer of tissue lining the rectum using radiofrequency (RF) energy in subjects suffering from radiation proctitis (acute inflammation of the inner lining of the rectum caused by the side effects of radiation treatments that can lead to bleeding).
In medical procedures, the RF energy used with this device, has been historically used in shrinking or removing soft-tissue, for surgical cutting, and for stopping bleeding. The device is cleared by the Food and Drug Administration (FDA) for use in coagulation (to assit with stoping bleeding and clotting of blood) of tissue within the digestive tract. The device has been used in areas outside the esophagus (inner lining of the throat), including the rectum to treat radiation proctitis. The stoppage of bleeding of radiation proctitis, using the HALO device, may be one method to control the bleeding.
The purpose of this study is to evaluate the effectiveness and record the results of treatment of radiation proctitis using the HALO device.
This study is intended to prospectively gather information regarding the performance of an endoscope-mounted radiofrequency (RF) energy device, which utilizes RF energy for the coagulation of gastrointestinal tissue in the setting of bleeding of radiation proctitis. The study device, the HALO90 Ablation catheter, has an FDA 510(k) clearance for human use.
The study design is a single-site, prospective clinical trial to gather performance data regarding a 510(k)-cleared, endoscopically-guided radiofrequency energy ablation device for the coagulation of hemorrhagic radiation proctitis.
Study subjects will have experienced bloody stools due to proctitis following pelvic radiation for cancers of the prostate or uterine endometrium. The study will include female and male adult patients who have received pelvic radiotherapy for such indications as cancer of the prostate or endometrium and have subsequently experienced recurrent hemorrhagic radiation proctitis.
As part of this protocol, focal areas of the epithelial lining of the diseased colon, rectum, and/or anus will be treated with the study device. The aim is to obtain information about the hemostatic effect of this device. The treatment settings evaluated in this study have been previously established with this device in the esophagus in "treat and resect" protocols, as well as in clinical trials for Barrett's esophagus with long-term follow-up.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
Device: HALO90 Ablation catheter
FDA approved endoscopic device for use in coagulation of tissue in the digestive tract using radiofrequency energy.
Also known as: Coagulation, Endoscopic Device
Number of Participants With Adverse Events
As this is a feasibility trial, the plan is to evaluate safety and efficacy in relation to adverse events in a small population (20 max) of patients.
Time frame: 1 year
| Milestone | Ablation Catheter |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
As this is a feasibility trial, the plan is to evaluate safety and efficacy in relation to adverse events in a small population (20 max) of patients.
| partipants | Ablation Treatment |
|---|---|
| Number of Participants With Adverse Events | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ablation Catheter | — | 1/1 (100%) | — |
| Event | Ablation Catheter |
|---|---|
| Rectal BleedingGastrointestinal disorders | 1/1 |
| Age, Categorical(Participants) | Ablation Catheter |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 1 |
| Age, Continuous(years) | Ablation Catheter |
|---|---|
| Mean | 77 |
| Sex: Female, Male(Participants) | Ablation Catheter |
|---|---|
| Female | 0 |
| Male | 1 |
| Region of Enrollment(participants) | Ablation Catheter |
|---|---|
| United States | 1 |
The record gives a start of Jul 2008, a primary completion of Jun 2009 and a completion of Jun 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2011, 1 year 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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University Hospitals Cleveland Medical Center →